| Appalachian 1173010 |
B-0225-5 |
43 – Platelets Pheresis |
Failure to control suspect component(s)
(inappropriate release-low platelet yield) |
$3,000 |
$156,000 |
| B-0226-5 |
9 – Platelets Pheresis Irradiated |
| Arizona 2072997 |
B-0493-4 |
1 – Fresh Frozen Plasma |
Failure to control suspect component(s) (inappropriate
release after discovery of clots in red blood cells) |
$3,000 |
$3,000 |
| Badger-Hawkeye 2173028 |
B-1681-4 |
1 –Platelets Pheresis Leukocytes Reduced
|
Failure to control suspect component(s) (inappropriate
release-quality control not completed ) |
$3,000 |
$3,000 |
| Carolinas Region
1073007 |
B-0948-5 |
1 – Red Blood Cells |
Failure to control suspect component(s) (failure
to quarantine after receiving post donation information) |
$3,000 |
$3,000 |
| B-0832-5 |
2 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$6,000 |
| B-0938-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (failure to defer donor
for lymphoma) |
$3,000 |
$3,000 |
| B-0933-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-0928-5 |
2 - Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$6,000 |
| B-0934-5 |
1 – Cryoprecipitated AHF |
Donor suitability (failure to defer donor
for CJD risk) |
$3,000 |
$3,000 |
| Central Ohio
1573013 |
B-1017-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability
(failure to follow SOPs—BDR high risk behavior answers
changed by Health Historian) |
$3,000 |
$6,000 |
| B-1018-4 |
1 – Recovered Plasma |
| B-0256-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Testing (recordkeeping error) |
$2,000 |
$2,000 |
| B-0513-4 |
1 - Platelets Pheresis Leukocytes Reduced
Irradiated |
Collection (sterility compromised) |
$2,000 |
$2,000 |
| B-0655-4 |
1 – Platelets Leukocytes Reduced |
Failure to control suspect component(s)
(inappropriate release after discovery of clots in red blood
cells) |
$3,000 |
$6,000 |
| B-0656-4 |
1 – Fresh Frozen Plasma |
| B-1066-4 |
4 - Red Blood Cells Pheresis Leukocytes Reduced |
Component preparation (low volume) |
No fine |
No fine |
| B-1013-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
defer donor for CJD risk) |
$3,000 |
$9,000 |
| B-1014-4 |
1 - Platelets Leukocytes Reduced |
| B-1015-4 |
1 - Recovered Plasma |
| B-1379-4 |
1 - Platelets Pheresis Leukocytes Reduced
Irradiated |
Component preparation (low volume) |
$2,000 |
$2,000 |
| Central Plains 1973042 |
B-1132-4 |
1 - Platelets Pheresis Leukocytes Reduced |
Re-release of unsuitable blood component |
$10,000 |
$10,000 |
Connecticut
1273014 |
B-0072-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (travel in malarial
risk area) |
$3,000 |
$6,000 |
| B-0073-4 |
1 – Platelets Leukocytes Reduced |
| B-0358-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
No fine |
No fine |
| B-0359-4 |
1 – Fresh Frozen Plasma |
| B-0546-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
$3,000 |
$6,000 |
| B-0547-4 |
1 – Platelets Leukocytes Reduced |
| B-0549-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
$3,000 |
$9,000 |
| B-0550-4 |
1 – Platelets Leukocytes Reduced |
| B-0551-4 |
1 – Recovered Plasma |
| B-0534-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
$3,000 |
$9,000 |
| B-0535-4 |
1 – Platelets Leukocytes Reduced |
| B-0536-4 |
1 – Fresh Frozen Plasma |
| B-0920-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
$3,000 |
$6,000 |
| B-0921-4 |
1 – Platelets Leukocytes Reduced |
| B-0923-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
$3,000 |
$6,000 |
| B-0924-4 |
1 – Platelets Leukocytes Reduced |
| B-0827-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (BDR questions unanswered) |
$3,000 |
$3,000 |
| B-1251-4 |
1 – Platelets Leukocytes Reduced |
Donor suitability (BDR questions unanswered) |
$3,000 |
$3,000 |
| B-1889-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
defer donor for CJD risk) |
$3,000 |
$9,000 |
| B-1890-4 |
1 – Platelets Leukocytes Reduced |
| B-1891-4 |
1 – Recovered Plasma |
| B-1655-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-1801-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (travel in malarial
risk area) |
$3,000 |
$6,000 |
| B-1802-4 |
1 – Platelets Leukocytes Reduced |
| B-0556-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| Greater Lakes 1873033
|
B-0743-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (BDR questions unanswered) |
$3,000 |
$3,000 |
| B-0793-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (BDR documentation missing
for SARS) |
$3,000 |
$3,000 |
| B-0966-4 |
2 – Fresh Frozen Plasma |
Failure to control suspect product
(inappropriate release after discovery of clots in red blood
cells) |
$3,000 |
$15,000 |
| B-0967-4 |
2 – Cryoprecipitated AHF |
| B-0968-4 |
1 - Cryoprecipitated AHF Pooled |
| B-0406-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
$3,000 |
$6,000 |
| B-0407-4 |
1 – Fresh Frozen Plasma |
| B-1940-4 |
32 – Red Blood Cells Leukocytes Reduced
|
Collection (inadequate arm scrub) |
$2,000 |
$96,000 |
| B-1941-4 |
1 – Cryoprecipitated AHF |
| B-1942-4 |
1 – Cryoprecipitated AHF Pooled |
| B-1943-4 |
5 – Platelets |
| B-1946-4 |
8 – Fresh Frozen Plasma |
| B-1944-4 |
1 – Plasma Cryoprecipitate Reduced |
| B-0477-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered) |
$3,000 |
$6,000 |
| B-0478-4 |
1 – Recovered Plasma |
| B-0739-4 |
1 – Red Blood Cells Leukocytes Reduced |
Component preparation (error in red cell recovery
calculation) |
No fine |
No fine |
| B-1342-4 |
2 – Red Blood Cells Pheresis |
Component preparation (record keeping error) |
$2,000 |
$4,000 |
| B-1519-4 |
1 – Plasma Cryoprecipitate Reduced |
Failure to control suspect component(s) (inappropriate
release after discovery of clots in red blood cells) |
$3,000 |
$3,000 |
| B-1578-4 |
1 – Platelets Pheresis Leukocytes Reduced
|
Collection (failure to follow
SOPs) |
$2,000 |
$4,000 |
| B-1579-4 |
1 – Platelets Pheresis Leukocytes Reduced
Irradiated |
| B-1118-4 |
1 – Platelets |
Failure to control suspect component(s) (after
supply defect discovered) |
$3,000 |
$3,000 |
| B-1198-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Failure to control suspect component(s) (inappropriate
release after discovery of low platelet yield) |
$2,000 |
$2,000 |
| B-1352-4 |
1 – Platelets Pheresis |
Component preparation (platelet yield and
volume out-of-specifications) |
$1,000 |
$1,000 |
| Greater Alleghenies
2573016 |
B-0595-4 |
1 – Red Blood Cells Leukocytes Reduced |
Testing (unresolved test results) |
No fine |
No fine |
| B-1055-4 |
6 – Platelets |
Failure to control suspect component(s) (inappropriate
release after discovery of low platelet yield) |
$3,000 |
$18,000 |
| B-2018-4 |
2 –Red Blood Cells Leukocytes Reduced
Irradiated |
Component preparation (recordkeeping errors
for irradiated components) |
$2,000 |
$4,000 |
| B-2019-4 |
1 –Red Blood Cells Leukocytes Reduced |
Donor suitability (an answer on BDR was “yes”
with no supporting documentation) |
$3,000 |
$3,000 |
| B-0219-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| A total of 3,279 blood components
were involved with this recall; approximately 382 of these
blood components were collected between the date the Decree
was entered on 4/15/2003. and the date the recall occurred
on 7/22/2003. |
Collection (inadequate arm scrub) |
$2,000 for
each of 100 components |
$200,000 |
| B-0881-5 |
Red Blood Cells |
| B-0882-5 |
Red Blood Cells Leukocytes Reduced |
| B-0883-5 |
Red Blood Cells Leukocytes Reduced Irradiated
|
| B-0884-5 |
Platelets |
| B-0885-5 |
Platelets Irradiated |
| B-0886-5 |
Fresh Frozen Plasma |
| B-0887-5 |
Plasma |
| B-0888-5 |
Red Blood Cells for Further Manufacture of
Non-Injectables |
| Greater Chesapeake
and Potomac 1173011 |
B-1603-4 |
8 – Platelets Pheresis Leukocytes Reduced |
Component preparation (failure to determine
white blood cell count) |
$2,000 |
$16,000 |
| B-1585-4 |
3 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$9,000 |
| B-1584-4 |
3 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$9,000 |
| B-1596-4 |
6 – Platelets Pheresis Leukocytes Reduced |
Collection (failure to follow manufacturer's
instructions) |
$2,000 |
$12,000 |
| B-1383-4 |
125 – Platelets Pheresis |
Failure to control suspect component(s) (failure
to perform QC testing) |
$3,000 for each of 100 blood components |
$300,000 |
| B-1586-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel/residency in malarial
risk area) |
$3,000 |
$3,000 |
| B-0799-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-0851-5 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
defer donor for taking Amiodarone) |
$3,000 |
$9,000 |
| B-0852-5 |
1 – Platelets |
| B-0853-5 |
1 – Fresh Frozen Plasma |
| Heart of America
1473043 |
B-0300-4 |
3 – Red Blood Cells Leukocytes Reduced |
Collection (sterility compromised) |
$2,000 |
$6,000 |
| B-1574-4 |
166 – Platelets Pheresis Leukocytes
Reduced |
Collection (failure to follow
manufacturer’s instructions) |
$2,000 for each of 100 blood components |
$200,000 |
| B-1575-4 |
34 – Platelets Pheresis Leukocytes Reduced
Irradiated |
| B-1576-4 |
47 – Fresh Frozen Plasma |
| B-1421-4 |
3 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$9,000 |
| B-1630-4 |
43 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (use of obsolete
SOP for CJD risk) |
$3,000 |
$237,000 |
| B-1632-4 |
4 – Platelets Pheresis Leukocytes Reduced
|
| B-1634-4 |
5 – Fresh Frozen Plasma |
| B-1635-4 |
4 – Frozen Plasma |
| B-1637-4 |
23 – Recovered Plasma |
| B-1622-4 |
2 – Platelets Pheresis |
Labeling (wrong product code) |
$2,000 |
$4,000 |
| B-1707-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
perform a complete search of donor information in the database) |
$3,000 |
$6,000 |
| B-1708-4 |
1 – Fresh Frozen Plasma |
| B-1722-4 |
2 – Platelets Pheresis Leukocytes Reduced |
Component preparation (failure to perform
QC testing) |
No fine |
No fine |
| B-1839-4 |
2 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$6,000 |
| B-1920-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (failure to defer donor
for cancer) |
$3,000 |
$3,000 |
| Indiana-Ohio
1873031 |
B-0053-5 |
2 – Red Blood Cells Leukocytes Reduced
(Splitunit) |
Failure to control suspect component(s) (failure
to quarantine components after receiving post donation information) |
$3,000 |
$6,000 |
| B-0096-5 |
1 - Red Blood Cells Leukocytes Reduced |
Component preparation (failure to collect
QC sample) |
$2,000 |
$2,000 |
| B-0854-4 |
3 – Red Blood Cells Leukocytes Reduced
|
Failure to control suspect component(s) (inappropriate
release of components that were to be discarded) |
$3,000 |
$9,000 |
| B-0142-5 |
2 – Platelets Pheresis |
Component preparation (volume too great for
one collection bag) |
$1,000 |
$2,000 |
| B-1811-4 |
155 – Red Blood Cells Leukocytes Reduced
|
Collection (inadequate arm scrub) |
$2,000 for each of 100 blood components |
$200,000 |
| B-1812-4 |
1 – Red Blood Cells Leukocytes Reduced
Irradiated |
| B-1813-4 |
25 – Platelets Leukocytes Reduced |
| B-1814-4 |
31 – Fresh Frozen Plasma |
| B-1518-4 |
1 – Red Blood Cells Leukocytes Reduced |
Failure to control suspect component(s) (quarantine
error with overweight unit) |
$3,000 |
$3,000 |
| Lewis and Clark
3072990 |
B-1843-4 |
6 – Cryoprecipitated AHF |
Failure to control suspect component(s)
(inappropriate release after discovery of clots in Red Blood
Cells) |
$3,000 |
$33,000 |
| B-1844-4 |
4 – Fresh Frozen Plasma |
| B-1845-4 |
1 – Plasma Cryporecititate Reduced |
| Mid-Atlantic
1173024 |
B-1011-4 |
13 – Red Blood Cells Leukocytes Reduced
|
Collections (sterility compromised) |
$2,000 |
$48,000 |
| 11 – Recovered Plasma |
| B-1720-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (failure to defer donor
with melanoma) |
$3,000 |
$3,000 |
| Missouri-Illinois
1973035 |
B-1512-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor deferral (duplicate donor
records) |
$2,000 |
$4,000 |
| B-1513-4 |
1 – Recovered Plasma |
| B-1524-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Failure to control suspect component(s) (inappropriate
release due to low platelet yield) |
$3,000 |
$3,000 |
| New England
1270026 |
B-0091-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-0810-4 |
15 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
ask and document BDR questions for SARS) |
$3,000 |
$51,000 |
| B-0811-4 |
1 – Red Blood Cells Leukocytes Reduced
Irradiated |
| B-0812-4 |
1 – Fresh Frozen Plasma |
| B-0755-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Failure to control suspect component(s) (inappropriate
release due to low platelet yield) |
$3,000 |
$3,000 |
| B-0723-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| A total of 16,393 blood components
were involved in this recall; approximately 7,330 of those
blood components were collected between the date of the entry
of the Decree on 4/15/2003 and the date of the recall on 3/8/2004.
|
Donor suitability (obsolete CJD
information sheet used) |
$3,000 for
each of 100 blood components |
$300,000 |
| B-0865-5 |
Red Blood Cells |
| B-0866-5 |
Red Blood Cells Pheresis |
| B-0868-5 |
Red Blood Cells Leukocytes Reduced |
| B-0869-5 |
Red Blood Cells Leukocytes Reduced Irradiated
|
| B-0870-5 |
Red Blood Cells Washed |
| B-0871-5 |
Red Blood Cells Leukocytes Reduced Washed |
| B-0872-5 |
Red Blood Cells Deglycerolized Leukocytes Reduced
|
| B-0873-5 |
Red Blood Cells Frozen |
| B-0875-5 |
Platelets Pheresis Leukocytes Reduced Irradiated
|
| B-0876-5 |
Platelets Pheresis Irradiated |
| B-1238-4 |
1 – Fresh Frozen Plasma |
Failure to control suspect component(s)
(inappropriate release after discovery of clots in red blood
cells) |
$3,000 |
$12,000 |
| B-1239-4 |
3 – Plasma Frozen Within 24 hours |
| B-1926-4 |
2 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$6,000 |
| B-1486-4 |
2 – Red Blood Cells Leukocytes Reduced
Irradiated |
Donor suitability (failure to
defer donor for hepatitis risk) |
$3,000 |
$9,000 |
| B-1487-4 |
1 – Recovered Plasma |
| B-1723-4 |
26 – Platelets Pheresis Leukocytes Reduced
|
Collection (failure to follow
manufacturer’s instructions) |
$2,000 |
$80,000 |
| B-1724-4 |
14 – Fresh Frozen Plasma |
| B-1475-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Component preparation (inappropriate volume) |
$2,000 |
$2,000 |
| B-1473-4 |
2 – Red Blood Cells |
Donor suitability (travel in malarial
risk area) |
$3,000 |
$9,000 |
| B-1474-4 |
1 – Red Blood Cells Leukocytes Reduced
|
| B-1479-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
defer donor for hepatitis risk) |
$3,000 |
$6,000 |
| B-1480-4 |
1 – Recovered Plasma |
| B-1803-4 |
5 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (BDR questions
unanswered for CJD) |
$3,000 |
$24,000 |
| B-1804-4 |
3 – Recovered Plasma |
| B-1904-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to determine hepatitis
risk) |
$3,000 |
$3,000 |
| B-0616-4 |
1 – Recovered Plasma |
Donor suitability (failure to defer donor
for CJD risk) |
$3,000 |
$3,000 |
| B-1832-4 |
2 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (use of obsolete
SOP for CJD risk) |
$3,000 |
$9,000 |
| B-1833-4 |
1 – Fresh Frozen Plasma |
| B-1645-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area). |
$3,000 |
$3,000 |
| B-1816-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (residence in malarial risk
area) |
$3,000 |
$3,000 |
| New York-Penn
2438445 |
B-0328-5 |
1 –Red Blood Cells Leukocytes Reduced |
Donor suitability (BDR questions unanswered) |
$3,000 |
$3,000 |
| B-0565-5 |
7 – Platelets Pheresis Leukocytes Reduced
|
Collection (failure to follow
manufacturer’s instructions) |
$2,000 |
$32,000 |
| B-0566-5 |
9 – Platelets Pheresis Leukocytes Reduced
Irradiated |
| B-0625-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-1295-4 |
1 – Platelets Pheresis Leukocytes Reduced
|
Component preparation (platelet
yield and plasma volume not adequate) |
$1,000 |
$2,000 |
| B-1296-4 |
1 – Platelets Pheresis Leukocytes Reduced
Irradiated |
| B-1762-4 |
2 – Platelets Pheresis Leukocytes Reduced
|
Donor suitability (travel in malarial
risk area) |
$3,000 |
$15,000 |
| B-1763-4 |
3 – Platelets Pheresis Leukocytes Reduced
Irradiated |
| B-0428-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-1838-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| Northern Ohio
1573019 |
B-0541-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel/residence in malarial
risk area) |
$3,000 |
$3,000 |
| B-0271-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Component preparation (no documentation of
white blood cell count for leukocytes reduced component) |
$2,000 |
$2,000 |
| B-0295-5 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
defer donor for hepatitis risk) |
$3,000 |
$9,000 |
| B-0298-5 |
1 – Platelets Leukocytes Reduced |
| B-0299-5 |
1 – Recovered Plasma |
| B-0439-5 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (failure to
defer donor for CJD risk) |
$3,000 |
$6,000 |
| B-0440-5 |
1 – Recovered Plasma |
| B-0545-4 |
1 – Red Blood Cells Pheresis |
Failure to control suspect component(s) (inappropriate
release without required testing) |
$3,000 |
$3,000 |
| B-0809-4 |
1 – Platelets Pheresis Leukocytes Reduced
|
Collection (sterility compromised) |
$2,000 |
$2,000 |
| B-1476-4 |
349 – Platelets Pheresis Leukocytes
Reduced; distributed between 3/19/2003 to 5/2/2003;120
of these blood components were distributed between the entry
of the Decree on 4/15/2003 and the date of the recall on 5/2/2003. |
Failure to control suspect component(s) (inappropriate
release without required testing) |
$2,000 for each of 100 blood components |
$200,000 |
| B-1381-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-1382-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Collection (sterility compromised) |
$2,000 |
$2,000 |
| B-1443-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Failure to control suspect component(s) (failure
to quarantine components after receiving post donation information) |
$3,000 |
$3,000 |
| B-1610-4 |
1 – Platelets Pheresis Leukocytes Reduced |
Failure to control suspect component(s) (failure
to quarantine after receiving post donation information) |
$2,000 |
$2,000 |
| Pacific Northwest
3072996 |
B-0040-5 |
1 – Plasma Cryoprecitate Reduced |
Component preparation (recordkeeping errors
related to freezing times) |
No fine |
No fine |
| B-0182-5 |
2 – Red Blood Cells |
Donor suitability (travel in a malarial risk
area) |
$3,000 |
$6,000 |
| B-0581-5 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-0768-5 |
255 – Cryoprecipitated AHF Pooled |
Component preparation (failure to perform
QC testing) |
$2,000 for each of 100 blood components |
$200,000 |
| B-1864-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (failure to follow donor
screening SOPs for hematocrit determination) |
$2,000 |
$2,000 |
| Penn-Jersey 2573021 |
B-1154-4 |
5 – Red Blood Cells Pheresis Leukocytes
Reduced |
Failure to control suspect component(s) (inappropriate
release of low volume component) |
$2,000 |
$10,000 |
| River Valley
1573003 |
B-1450-4 |
1 – Cryoprecipitated AHF |
Failure to control suspect component(s) (inappropriate
release after discovering clots in red blood cells) |
$3,000 |
$3,000 |
| B-1531-4 |
12 – Whole Blood |
Collection (inadequate arm scrub) |
$2,000 for each of 100 blood components |
$200,000 |
| B-1532-4 |
26 – Red Blood Cells |
| B-1533-4 |
333 – Red Blood Cells Leukocytes Reduced
|
| B-1534-4 |
25 – Red Blood Cells Leukocytes Reduced
Irradiated |
| B-1535-4 |
70 – Platelets |
| B-1536-4 |
9 – Platelets Irradiated |
| B-1537-4 |
108 – Fresh Frozen Plasma |
| B-1538-4 |
6 – Cryoprecipitated AHF |
| B-1593-4 |
39 – Platelets Pheresis |
Collection (collection kits not
used within acceptable time period) |
$2,000 |
$90,000 |
| B-1594-4 |
5 – Platelets Pheresis Leukocytes Reduced
|
| B-1595-4 |
1- Fresh Frozen Plasma |
| Southeastern
Michigan 1873044 |
B-0311-5 |
85 – Red Blood Cells Leukocytes Reduced
|
Collection (failure to follow
manufacturer’s instructions) |
$2,000 for each of 100 blood components |
$200,000 |
| B-0312-5 |
45 – Platelets Leukocytes Reduced |
| B-0320-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-0380-4 |
1 – Red Blood Cells Leukocytes Reduced |
Component preparation (failure to follow SOPs-red
blood cells prepared >8 hours after collection) |
$2,000 |
$2,000 |
| B-0563-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-0776-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| B-0819-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Component preparation (overweight
unit) |
$2,000 |
$4,000 |
| B-0820-4 |
1 – Platelets Leukocytes Reduced |
| B-1484-4 |
2 – Red Blood Cells Pheresis |
Failure to control suspect component(s) (inappropriate
release of low volume components) |
$2,000 |
$4,000 |
| B-0774-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (residence in
malarial risk area) |
$3,000 |
$6,000 |
| B-0775-4 |
1 – Platelets |
| B-0821-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| Southern California 2072994 |
B-0756-4 |
4 – Fresh Frozen Plasma |
Failure to control suspect component(s) (inappropriate
release due to clots) |
$3,000 |
$12,000 |
| Southwest 1673040
|
B-1912-4 |
1 – Red Blood Cells Leukocytes Reduced
|
Donor suitability (residence in
malarial risk area) |
$3,000 |
$12,000 |
| B-1913-4 |
1 – Red Blood Cells Leukocytes Reduced
Irradiated |
| B-1914-4 |
2 – Platelets Leukocytes Reduced |
| B-1910-4 |
1 – Red Blood Cells Leukocytes Reduced |
Donor suitability (travel in malarial risk
area) |
$3,000 |
$3,000 |
| Western Lake Erie 1573020 |
B-1704-3 |
1 – Platelets Pheresis Leukocytes Reduced |
Component preparation (low platelet yield) |
No fine |
No fine |
