CLASS II RECALLS FOR THE PERIOD 4/15/03 THROUGH 4/15/05
(EXCLUDING THOSE
PREVIOUSLY ADDRESSED IN THE MAY 15, 2005 PARAGRAPH X ADVERSE
DETERMINATION LETTER)
The following regions have no recall information included
in this report:
Region/CFN |
Biological
Product Deviation Number/ Recall Number |
Number of
Recalled Products/Product Type |
Reason for
Recall |
Penalty Amount
Per Blood Component |
Total Penalty
Amount |
Appalachian
1173010 |
2004-035-0621471
B-2423-5 |
1 – Red Blood Cells |
Failure to control suspect blood
component(s) (inappropriate release-enzyme immunoassay (EIA)
positive hepatitis B core) |
$5,000 |
$5,000 |
Arizona
2072997 |
2004-007-0416380
B-1480-5 |
1 - Red Blood Cells Leukocytes Reduced
Irradiated |
Component preparation (discrepant
irradiation times documented) |
$3,000 |
$3,000 |
2004-007-0575401
B-0390-5 |
6 –Platelets Pheresis Leukocytes
Reduced |
Component preparation (no confirmation
of leukocyte reduction) |
$4,000 |
$24,000 |
2004-007-0649384
B-1763-5B-1764-5 |
1 - Platelets Pheresis Leukocytes
Reduced
Irradiated
1 – Fresh Frozen Plasma Pheresis |
Donor eligibility (Blood Donation
Record (BDR) question unanswered) |
$3,000 |
$6,000 |
Badger-Hawkeye
2173028 |
2003-03-20217889
B-1676-4
B-1677-4
B-1678-4 |
1 - Red Blood Cells Leukocytes Reduced
1 - Platelets Leukocytes Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (failure to defer
donor for increased risk of infection with hepatitis) |
$4,000 |
$12,000 |
Carolinas
Region 1073007 |
2004-012-0715488
B-0999-5 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2004-012-0505489
B-1019-5
B-1020-5 |
3 - Red Blood Cells Leukocytes Reduced
1 – Plasma Frozen |
Donor eligibility (failure to follow
standard operating procedures (SOPs) for donors unable to answer
health questions on their own) |
$2,000 |
$8,000 |
2003-012-0122163
B-2381-5 |
1 - Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2003-012-0176772
B-1201-5 |
1 - Red Blood Cells Leukocytes Reduced |
Testing (sample tube mislabeling
mix-up) |
$5,000 |
$5,000 |
2003-012-0210391
B-0078-6 |
3 - Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$12,000 |
2004-012-0343049
B-1953-5 |
1 - Red Blood Cells Leukocytes Reduced |
Failure to control suspect blood
component(s) (unit not placed on hold when deviation on BDR
was found) |
$5,000 |
$5,000 |
2004-012-0370556
B-0715-6 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2004-012-0378599
B-2382-5 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2004-012-0379026
B-2380-5 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2004-012-0398025
B-0931-6
B-0932-6 |
1 - Red Blood Cells Leukocytes Reduced
1 – Recovered Plasma |
Failure to control suspect blood
component(s) (inappropriate release of products from a deferred
donor) |
$5,000 |
$10,000 |
2004-012-0456922
B-0888-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Failure to control suspect blood
component(s) (products were not discarded after discovery of
an error on the BDR) |
$5,000 |
$5,000 |
2004-012-04868895
B-0887-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in a malarial
risk area) |
$4,000 |
$4,000 |
2004-012-0544145
B-0716-6 |
2 – Red Blood Cells Pheresis
Leukocytes Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$8,000 |
2004-012-0559097
B-0860-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Failure to control suspect blood
component(s) (intended for validation study) |
$5,000 |
$5,000 |
2004-012-0577082
B-0885-6
B-0886-6 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (BDR question related
to Creutzfeldt Jakob Disease (CJD) was unanswered) |
$4,000 |
$8,000 |
2004-012-0589867
B-2384-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in a malarial
risk area) |
$4,000 |
$4,000 |
2004-012-0603330
B-0175-6 |
1 – Platelets Pheresis Leukocytes
Reduced |
Component preparation (platelet yield
too high for storage in a single bag) |
$4,000 |
$4,000 |
2004-012-0631857
B-0738-6 |
1 – Platelets Pheresis Leukocytes
Reduced |
Collection (failure to follow manufacturer’s
instructions) |
$3,000 |
$3,000 |
2004-012-0719187
B-0994-5 |
1 – Platelets Pheresis Leukocytes
Reduced |
Failure to control suspect blood
component(s) (inappropriate release after noting discrepant
information on the apheresis procedure record) |
$5,000 |
$5,000 |
2005-012-0810629
B-2026-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2005-012-0821156
B-1928-5 |
1 - Platelets Pheresis Leukocytes
Reduced |
Collection (failure to follow manufacturer’s
instructions) |
$3,000 |
$3,000 |
2005-012-0882462
B-0415-6 |
17 – Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$68,000 |
2005-012-0931808
B-0452-6
B-0453-6 |
1 – Red Blood Cells Leukocytes
Reduced
3 – Platelets Pheresis Leukocytes Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$16,000 |
2004-012-0358460
B-0867-6
B-0868-6B-0869-6
B-0870-6B-0871-6
B-0872-6
B-0873-6 |
7 - Red Blood Cells Leukocytes
Reduced
4 – Red Blood Cells Pheresis Leukocytes Reduced
6 – Platelets Pheresis Leukocytes Reduced
4 – Platelets Pheresis Leukocytes Reduced Irradiated
2 – Plasma Frozen Cryoprecipitate Reduced
2 – Cryoprecipitate AHF
4 – Recovered Plasma |
Failure to control suspect blood
component(s) (units not placed on hold when deviation on BDRs
were found) |
$5,000 |
$145,000 |
Central
Ohio 1573013 |
2004-016-0431548
B-2005-4 |
1 -
Platelets Pheresis Leukocytes Reduced Irradiated |
Failure to control suspect blood
component(s) (inappropriate release after discovery of low platelet
yield) |
$5,000 |
$5,000 |
2004-016-0449876
B-2012-4 |
2 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (quality control
(QC)for Hemastat could not be verified) |
$3,000 |
$6,000 |
Connecticut
1273014 |
B-0116-5 |
2 – Red Blood Cells Pheresis
– Split Unit |
Component preparation (failure to
perform quality control testing) |
$3,000 |
$6,000 |
B-0541-5 |
1 – Red Blood Cells Pheresis |
Failure to control suspect blood
component(s) (low volume Red Blood Cells) |
$5,000 |
$5,000 |
B-1237-5
B-1238-5
B-1239-5
B-1240-5 |
2 – Red Blood Cells Leukocytes
Reduced
2 – Platelets Leukocytes Reduced
2 – Fresh Frozen Plasma
2 – Recovered Plasma |
Donor eligibility (travel in a CJD
risk area) |
$4,000 |
$32,000 |
Great
Lakes 1873033 |
2004-018-0386370
B-1672-4 |
1 – Platelets Pheresis Leukocytes
Reduced |
Failure to control suspect blood
component(s) (product intended for validation study) |
$5,000 |
$5,000 |
2004-018-0474355
B-0067-5
B-0068-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Recovered Plasma |
Failure to control suspect blood
component(s) (sterility may have been compromised) |
$5,000 |
$10,000 |
2004-018-0503561
B-0072-5
B-0073-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (failure to follow
up on medications taken by donor) |
$2,000 |
$4,000 |
2004-018-0631286
B-0549-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (hematocrit result
was not documented) |
$3,000 |
$3,000 |
2004-018-0687247
B-0595-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (hemoglobin was
unsatisfactory and hematocrit not documented) |
$3,000 |
$3,000 |
2005-018-0751704
B-1112-5
B-1113-5 |
2 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (failure to follow
SOPs for travel outside the U.S.) |
$4,000 |
$12,000 |
2005-018-1081407
B-0587-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2005-018-1008818
B-0602-6 |
2 – Red Blood Cells Pheresis |
Collection (sterility may have been
compromised and failure to follow manufacturer’s instructions)
|
$5,000 |
$10,000 |
Greater
Alleghenies 2573016 |
B-0208-5 |
1 – Platelets Pheresis Leukocytes
Reduced |
Component preparation (failure to
determine white blood cell count and failure to follow manufacturer’s
instructions) |
$4,000 |
$4,000 |
B-0209-5 |
2 – Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (failure to defer
donor for taking Feldene) |
$2,000 |
$4,000 |
B-0904-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
B-0924-5 |
1 – Red Blood Cells Pheresis
Leukocytes Reduced |
Failure to control suspect blood
component(s) (unit not tagged for hematocrit testing after device
malfunction) |
$5,000 |
$5,000 |
B-1337-5
B-1338-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Cryoprecipitated AHF |
Donor eligibility (failure to defer
donor for taking Avodart) |
$5,000 |
$10,000 |
B-1396-5 |
1 – Platelets Pheresis Leukocytes
Reduced |
Component preparation (platelet yield
too high for single bag) |
$4,000 |
$4,000 |
B-1890-5
B-1891-5
B-1892-5 |
2 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma
2 – Recovered Plasma |
Donor eligibility (failure to defer
donor for CJD risk) |
$4,000 |
$20,000 |
B-1944-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to defer
donor who reported taking medication on the Medication Deferral
List) |
$5,000 |
$5,000 |
B-0320-6B-0313-6B-0317-6
B-0311-6
B-0314-6
B-0315-6
B-0318-6
B-0312-6B-0316-6
B-0319-6
B-0321-6 |
1 – Red Blood Cells CPDA-1
for Manufacturing Non-Injectables
2 – Red Blood Cells Pheresis Leukocytes
Reduced
3 – Liquid Plasma
2,121 – Red Blood Cells Leukocytes Reduced
278 – Platelets Leukocytes Reduced
1 – Platelet Pheresis Leukocytes Reduced
176 – Cryoprecipiated AHF
36 – Red Blood Cells Leukocytes Reduced Irradiated
332 – Fresh Frozen Plasma
44 – Plasma Cryoprecipitated AHF
1755 – Recovered Plasma |
Donor eligibility (use of obsolete
CJD information form ) |
$4,000 for each
of 100 blood components |
$400,000 |
Greater
Chesapeake and Potomac 1173011 |
2004-053-0420855
B-0480-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility ( BDR question
pertaining to Avodart unanswered) |
$5,000 |
$5,000 |
2004-053-0571810
B-0763-5 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility ( failure to defer
donor for taking Tazorac) |
$2,000 |
$2,000 |
2004-053-0560252
B-0765-5 |
3 – Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$12,000 |
2004-053-0517279
B-0766-5 |
2 – Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$8,000 |
2004-053-0580808
B-0841-5
B-0842-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Recovered Plasma |
Donor eligibility (failure to defer
donor for history of hepatitis) |
$4,000 |
$8,000 |
2004-053-0689598
B-1580-5
B-1581-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma |
Failure to control suspect blood
component(s) (quarantine error with overweight unit) |
$5,000 |
$10,000 |
Greater
Ozarks-Arkansas
2372998 |
2004-055-0413840
B-2020-5
B-2021-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (failure to defer
donor for hepatitis risk) |
$4,000 |
$8,000 |
2003-055-0219886
B-2073-5 |
4 – Fresh Frozen Plasma |
Failure to control suspect blood
component(s) (inappropriate release after discovering clots
in red blood cells) |
$5,000 |
$20,000 |
2003-055-0280152
B-2121-5 |
156 – Platelets Pheresis Leukocytes
Reduced |
Component preparation (failure to
perform monthly QC for platelet pheresis products) |
$3,000 for each
100 blood components |
$300,000 |
2003-055-0136101
B-2202-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Failure to control suspect blood
component(s) (inappropriate release after reactive West Nile
pool was reported) |
$5,000 |
$5,000 |
2005-055-0953356
B-0689-6
B-0691-6
B-0692-6 |
5 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma
3 – Recovered Plasma |
Donor eligibility (failure to defer
donor for hepatitis risk) |
$4,000 |
$36,000 |
Heart
of America 1473043 |
2004-040-0643167
B-0465-5 |
1 – Platelets Pheresis Leukocytes
Reduced |
Failure to control suspect blood
component(s) (sterility may have been compromised) |
$5,000 |
$5,000 |
2004-040-0642930
B-0466-5 |
3 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$12,000 |
2004-040-0642994
B-0467-5 |
3 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$12,000 |
2005-040-0804626
B-1327-5
B-1328-5 |
1 – Platelets Pheresis Leukocytes
Reduced
1 – Platelets Pheresis Leukocytes Reduced Irradiated |
Collection (failure to follow manufacturer’s
instructions) |
$3,000 |
$6,000 |
2005-040-0886454
B-1679-5 |
3 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to document
the hematocrit reading) |
$3,000 |
$9,000 |
2005-040-1175515
B-0728-6 |
1 – Red Blood Cells |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
Indiana-Ohio
1873031 |
2005-038-0799491
B-1104-5 |
1 – Red Blood Cells |
Failure to control suspect blood
component(s) (inappropriate release after receiving post donation
information) |
$5,000 |
$5,000 |
2004-038-0348688
B-1114-5
B-1115-5
B-1116-5
B-1118-5
B-1119-5
B-1120-5 |
4 – Red Blood Cells
189 - Red Blood Cell, Leukocytes Reduced
18 – Platelets
1 – Platelets Irradiated
30 - Fresh Frozen Plasma
141 - Recovered Plasma |
Donor eligibility (use of obsolete
SOP for CJD risk) |
$4,000 for each
of 100 blood components |
$400,000 |
2005-038-0867114
B-1815-5 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
Lewis
and Clark 3072990 |
2003-020-0079860
B-0721-6 |
1 – Red Blood Cells Leukocytes Reduced |
Donor eligibility (BDR question
unanswered) |
$3,000 |
$3,000 |
2003-020-0221986
B-0211-6
B-0212-6
B-0213-6 |
2 – Fresh Frozen Plasma
1 – Plasma Cryoprecipitated Reduced
1 – Cryoprecipitated AHF |
Failure to control suspect blood
component(s) (inappropriate release after discovery of clots
in red blood cells) |
$5,000 |
$20,000 |
2003-020-0279664
B-0630-6
B-0631-6 |
34 – Platelets Pheresis Leukocytes
Reduced
5 – Platelets Pheresis Leukocytes Reduced Irradiated |
Component preparation (failure to
perform QC testing) |
$3,000 |
$117,000 |
Mid-Atlantic
1173024 |
2004-029-0594370
B-0445-5 |
1 – Platelets Pheresis Leukocytes
Reduced Irradiated |
Component preparation (volume too
great for one collection bag) |
$4,000 |
$4,000 |
2004-029-0606242
B-0461-5
B-0462-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Frozen Plasma |
Donor eligibility (failure to defer
donor for CJD risk) |
$4,000 |
$8,000 |
2004-029-0700521
B-1538-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
Missouri-Illinois
1973035 |
2005-011-0797069
B-0638-6 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility (donor incorrectly
removed from the National Donor Deferral Registry) |
$5,000 |
$5,000 |
2005-011-0793209
B-0684-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
New
England 1270026 |
B-1888-4 |
1 – Platelets Pheresis Leukocytes
Reduced |
Collection (failure to follow manufacturer’s
instructions) |
$3,000 |
$3,000 |
B-0501-5 |
1 – Red Blood Cells |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
B-0502-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
B-0670-5 |
1 – Platelets Pheresis Leukocytes
Reduced Irradiated |
Collection (sterility may have been
compromised and failure to follow manufacturer’s instruction) |
$5,000 |
$5,000 |
B-0723-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
B-0947-5 |
2 - Platelets Pheresis Leukocytes
Reduced |
Collection (sterility may have been
compromised and failure to follow manufacturer’s instructions) |
$5,000 |
$10,000 |
B-0951-5 |
1 - Red Blood Cells Leukocytes Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
B-0956-5 |
1 – Red Blood Cells |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
B-1006-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
B-1007-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
B-1009-5 |
1 – Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (failure to defer
donor for taking Proscar) |
$5,000 |
$5,000 |
B-1023-5 |
1 – Fresh Frozen Plasma |
Failure to control suspect blood
component(s) (inappropriate release after discovery of clots
in red blood cells) |
$5,000 |
$5,000 |
B-1996-5
B-1997-5 |
2 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (failure to defer
donor for taking Proscar) |
$5,000 |
$15,000 |
B-2005-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
B-0625-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malaria
risk area) |
$4,000 |
$4,000 |
New York-Penn
2438445 |
2004-001-0532479
B-2253-5
B-2254-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Recovered Plasma |
Donor eligibility (failure to defer
donor for hepatitis risk) |
$4,000 |
$8,000 |
North
Central
2173038 |
2003-017-0112629
B-0424-6 |
1 – Platelets Leukocytes Reduced |
Donor eligibility (failure to defer
donor for HIV risk) |
$5,000 |
$5,000 |
2003-017-0114568
B-0503-6 |
1 – Platelets Leukocytes Reduced |
Component preparation (sterility
may have been compromised) |
$5,000 |
$5,000 |
2004-017-0320991
B-1097-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Failure to control suspect blood
component(s) (overweight unit) |
$5,000 |
$5,000 |
2004-017-0464920
B-1113-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2004-017-0466796
B-1131-6 |
2 – Red Blood Cells Leukocytes
Reduced |
Component preparation (failure to assure leukoreduction) |
$4,000 |
$8,000 |
Northeastern
Pennsylvania
2573018 |
B-0069-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (hemoglobin not
documented) |
$3,000 |
$3,000 |
B-0671-5 |
1 – Whole Blood |
Donor eligibility (failure to defer
donor for urinary tract infection) |
$4,000 |
$4,000 |
B-0656-5 |
2 – Red Blood Cells Leukocytes
Reduced |
Collections (error on daily quality
control record) |
$3,000 |
$6,000 |
B-1853-5 |
1 – Red Blood Cells |
Failure to control suspect blood
component(s) (OC was not properly performed on the hematocrit
centrifuge) |
$5,000 |
$5,000 |
B-1852-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to have
a hematocrit value on the BDR) |
$3,000 |
$3,000 |
B-2375-5
B-2376-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Cryoprecipitate AHF |
Donor eligibility (failure to defer
donor with melanoma) |
$4,000 |
$8,000 |
B-0233-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
Northern
Ohio 1573019 |
2004-042-0686603
B-2141-5
B-2142-5
B-2143-5B-2144-5B-2145-5
B-2146-5
B-2147-5 |
6 – Red Blood Cells
719 – Red Blood Cells Leukocytes Reduced
1 – Red Blood Cells Leukocytes Reduced Washed
50 – Red Blood Cells Apheresis Leukocytes Reduced
249 – Platelets Leukocytes Reduced
107 – Fresh Frozen Plasma
15 – Plasma |
Donor eligibility (inadequate donor
screening) |
$5,000 for each
of 100 blood components |
$500,000 |
2005-042-0931991
B-0158-6 |
1 – Platelets Pheresis Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
Pacific
Northwest 3072996 |
2003-021-0223957
B-0492-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Collection (sterility may have been
compromised and failure to follow manufacturer’s instructions) |
$5,000 |
$5,000 |
2004-021-0292966
B-1407-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2004-021-0308462
B-1426-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to
malarial risk area) |
$4,000 |
$4,000 |
2004-021-0346465
B-0479-6
B-0480-6 |
1 – Red Blood Cells Leukocytes
Reduced
5 – Platelets Pheresis Leukocytes Reduced |
Donor eligibility (travel to malaria
risk area) |
$4,000 |
$24,000 |
Penn-Jersey
2573021 |
B-2037-4 |
1 – Red Blood Cells Pheresis |
Component preparation (sterility
may have been compromised and failure to follow manufacturer’s
instructions) |
$5,000 |
$5,000 |
B-2051-4 |
1 – Red Blood Cells Pheresis |
Component preparation (sterility
may have been compromised and failure to follow manufacturer’s
instructions) |
$5,000 |
$5,000 |
B-0819-5 |
5 – Red Blood Cells Leukocytes
Reduced |
Collections (daily QC of Hematastat
was unacceptable) |
$3,000 |
$15,000 |
B-0834-5B-0835-5 |
5 – Red Blood Cells Leukocytes
Reduced Irradiated
6 – Platelets Pheresis Leukocytes Reduced Irradiated |
Component preparation (discrepant
irradiation times documented) |
$3,000 |
$33,000 |
B-1434-5
B-1435-5 |
221 – Platelets Pheresis Leukocytes
Reduced 27 – Platelet Pheresis Leukocytes Reduced
Irradiated |
Component preparation (monthly QC
of pheresis products not performed) |
$3,000 for each
of 100 blood components |
$300,000 |
B-1531-5
B-1532-5B-1533-5 |
1976 – Platelets Pheresis Leukocytes
Reduced 736 – Platelets Pheresis Leukocytes
Reduced Irradiated
1635 – Fresh Frozen Plasma |
Component preparation (manufacturer’s
instructions were updated but written procedures had not been
updated) |
$4,000 for each
of 100 blood components |
$400,000 |
B-1542-5
B-1543-5 |
1 – Red Blood Cells Leukocyte
Reduced
1 – Fresh Frozen Plasma |
Failure to control suspect blood
component(s) (failure to quarantine components after receiving
post
donation information) |
$5,000 |
$10,000 |
B-1749-5 |
1 – Red Blood Cells |
Failure to control suspect blood
component(s) (overweight units) |
$5,000 |
$5,000 |
B-1881-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
B-1882-5 |
1 – Platelets Leukocytes Reduced |
Donor eligibility (failure to defer
donor for HIV risk) |
$5,000 |
$5,000 |
B-1906-5 |
13 – Platelets Pheresis Leukocytes
Reduced |
Storage/Shipping (shipment of products
exceeded time allowed for shipping) |
$4,000 |
$52,000 |
River Valley
1073003 |
2004-024-0324987
B-1759-5
B-1760-5 |
730 – Platelets Leukocytes
Reduced
90 – Platelets Leukocytes Reduced Irradiated |
Component preparation (low platelet
yields) |
$4,000 for each
of 100 blood components |
$400,000 |
South
Carolina
1073009 |
2003-036-0157079
B-0965-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to defer
donor for taking Lupron) |
$2,000 |
$2,000 |
2005-036-0859145
B-1009-6 |
5 – Platelets Pheresis Leukocytes
Reduced |
Storage/Shipping (time in transit
not documented) |
$2,000 |
$10,000 |
2005-036-0978405
B-0921-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to defer
donor for lymphoma) |
$4,000 |
$4,000 |
Southeastern
Michigan 1873044 |
2004-013-0403966
B-1424-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2004-013-0652182
B-1425-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2004-013-0514574
B-1454-5
B-1455-5
B-1456-5 |
1 - Red Blood Cells Leukocytes Reduced
1 – Platelets Leukocytes Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (failure to defer
donor for human T lymphotropic virus (HTLV) risk) |
$4,000 |
$12,000 |
2004-013-0588706
B-1483-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2005-013-0813171
B-2292-5
B-2293-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Fresh Frozen Plasma |
Donor eligibility (failure to deter
donor for taking Avodart) |
$5,000 |
$10,000 |
2005-013-0979194
B-0015-6 |
1 – Platelets Pheresis Leukocytes
Reduced Irradiated |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2005-013-0948006
B-0038-6
B-0039-6 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Platelets Leukocytes Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$8,000 |
2004-013-0414712
B-0124-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to defer
donor for HTLV risk) |
$4,000 |
$4,000 |
Southern
1073000 |
2003-003-0268123
B-0445-6 |
3 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$12,000 |
2003-003-0137009
B-0447-6 |
10 – Red Blood Cells Leukocytes
Reduced |
Failure to control suspect blood
component(s) (overweight unit) |
$5,000 |
$50,000 |
2003-003-0171218
B-0519-6 |
1 Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel in malarial
risk area) |
$4,000 |
$4,000 |
2004-003-0655027
B-0736-6 |
1 – Platelets Pheresis Leukocytes
Reduced |
Component preparation (inappropriate
release of unit with unacceptable platelet yield) |
$4,000 |
$4,000 |
2004-003-0362554
B-0737-6 |
1 – Platelets Pheresis |
Component preparation (inappropriate
release of unit with unacceptable platelet yield) |
$4,000 |
$4,000 |
2004-003-0508176
B-0762-6 |
1 – Platelets Pheresis Leukocytes
Reduced |
Component preparation (inappropriate
release of unit with unacceptable platelet yield) |
$4,000 |
$4,000 |
2004-003-0366103
B-0807-6 |
1 – Platelets Pheresis |
Failure to control suspect blood
component(s) (BDR questions related to HIV risk were unanswered) |
$5,000 |
$5,000 |
2004-003-0591717
B-0895-6 |
3 – Plasma Frozen |
Failure to control suspect blood
component(s) (inappropriate release after discovering clots
in red blood cells) |
$5,000 |
$15,000 |
2004-003-0424198
B-0896-6 |
1 – Platelets Pheresis Leukocytes
Reduced |
Component preparation (inappropriate
release of unit with unacceptable platelet yield) |
$4,000 |
$4,000 |
2004-003-0577474
B-0947-6 |
2 – Platelets Pheresis Leukocytes
Reduced |
Failure to control suspect blood
component(s) (product did not meet product specifications) |
$5,000 |
$10,000 |
2004-003-0339931
B-1008-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Failure to control suspect blood
component(s) (BDR high risk question unanswered) |
$5,000 |
$5,000 |
Southern
California 2072994 |
2003-006-0186567
B-0624-4 |
1 – Red Blood Cells Leukocytes
Reduced |
Storage/Shipping (product stored
at incorrect temperature) |
$4,000 |
$4,000 |
2004-006-036788
B-1045-5 |
2 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$8,000 |
2004-006-0360704
B-1049-5
B-1050-5 |
2 – Red Blood Cells
1 – Fred Frozen Plasma |
Donor eligibility (failure to defer
donor for body piercing) |
$4,000 |
$12,000 |
2004-006-0325150
B-1768-5
B-1769-5 |
5 – Platelets Pheresis Leukocytes
Reduced
1 – Platelets Pheresis Irradiated |
Component preparation (failure to
perform product QC testing) |
$3,000 |
$18,000 |
2004-006-0321033
B-1910-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2003-006-0230785
B-0277-6 |
2 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$8,000 |
2004-006-0375556
B-0672-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2003-006-0155824
B-0834-6 |
1 – Platelets Pheresis Irradiated |
Failure to control suspect blood
component(s) (inappropriate release-elevated platelet count) |
$5,000 |
$5,000 |
2004-006-0501165
B-1176-6 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
Southwest
1673040 |
2003-0490152156
B-1652-5
B-1653-5 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Recovered Plasma |
Donor eligibility (failure to defer
donor for taking Proscar) |
$5,000 |
$10,000 |
2003-049-0226992
B-1680-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to defer
donor for low Hct) |
$3,000 |
$3,000 |
2004-049-0709793
B-1698-5 |
1 – Platelets Pheresis Leukocytes
Reduced |
Collection (sterility may have been
compromised) |
$5,000 |
$5,000 |
2003-049-0182598
B-1699-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (failure to defer
donor for unacceptable hemoglobin level) |
$3,000 |
$3,000 |
2004-049-0564594
B-1726-5 |
1 – Red Blood Cells Leukocytes
Reduced |
Donor eligibility (travel to malarial
risk area) |
$4,000 |
$4,000 |
2004-049-0620192
B-1739-5 |
2 – Platelets Pheresis Leukocytes
Reduced |
Failure to control suspect blood
component(s) (product intended for validation study) |
$5,000 |
$10,000 |
2005-049-0819904
B-0877-6 |
1 – Red Blood Cells |
Donor Eligibility (BDR question pertaining
to CJD was unanswered) |
$4,000 |
$4,000 |
Western
Lake Erie 1573020 |
2004-050-0305012
B-0082-6
B-0083-6
B-0084-6 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Cryoprecipitated, AHF
1 – Recovered Plasma |
Donor eligibility (failure to defer
donor for CJD risk) |
$4,000 |
$12,000 |
2004-050-0654999
B-1000-6
B-1001-6
B-1002-6 |
1 – Red Blood Cells Leukocytes
Reduced
1 – Cryoprecipitated AHF
1 – Recovered Plasma |
Donor eligibility (failure to defer
donor for hepatitis risk) |
$4,000 |
$12,000 |