Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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December 1, 2004
04-48

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0254-5;
b) Recovered Plasma. Recall # B-0255-5.
CODE
a) and b) Unit KS08907.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annadale, VA, by letter and fax dated April 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and NJ.

_______________________________
PRODUCT
Source Plasma. Recall # B-0261-5.
CODE
Unit 70082463.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Services, Inc., Kansas City, MO, by letter dated March 10, 2003. Firm initiated recall is complete.
REASON
Source Plasma, with an elevated ALT level, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0262-5.
CODE
Units 50636655, 41164570, 41150375, 41147368, 41115633, 41113127,
41127872, 28529132, 526872.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Services, Inc., Kansas City, MO, by facsimile dated April 28, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
CA

_______________________________
PRODUCT
Human Corneal Tissue. Recall # B-0263-5.
CODE
SL04-05-048R1 & SL04-05-048L1.
RECALLING FIRM/MANUFACTURER
Mid-America Transplant Services, Olivette, MO. by letter dated August 13, 204. Firm initiated recall is complete.
REASON
Tissue, procured from a donor who engaged in high-risk activity, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
Mexico.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-0267-5.
b) Fresh Frozen Plasma. Recall # B-0268-5.
Problem:
CODE
a) and b) Unit number: 224292744.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on July 22, 2002 and by letter dated August 9, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to the use of the medication, Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NV.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-0269-5;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0270-5;
CODE
a) Unit numbers: 150258768 (Parts 1 & 2);
b) Unit number: 150258768.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by letter, on May 18, 2004 and August 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0271-5;
b) Platelets, Leukocytes Reduced. Recall # B-0272-5.
CODE
a) and b) Unit number 0982259.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letters on May 28, 2004, and August 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0275-5.
CODE
Unit numbers 15025-1722 (distributed as two split products) and 15025-2418.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on January 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Whole Blood, Leukocytes Reduced. Recall # B-0277-5;
b) Red Blood Cells. Recall # B-0278-5;
c) Red Blood Cells, Leukocytes Reduced. Recall # B-0279-5;
d) Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-0280-5;
e) Platelets. Recall # B-0281-5;
f) Platelets, Pooled (Recall # B-0282-5;
g) Platelets Pheresis, Leukocytes Reduced. Recall # B-0283-5;
h) Cryoprecipitated AHF. Recall # B-0284-5;
i) Cryoprecipitated AHF, Pooled. Recall # B-0285-5;
j) Fresh Frozen Plasma. Recall # B-0286-5;
k) Fresh Frozen Plasma (Apheresis). Recall # B-0287-5;
l) Plasma, Cryoprecipitate Reduced. Recall # B-0288-5.
CODE
a) Unit numbers KZ66299, KZ69840, and KZ68404;
b) Unit numbers KZ65297, KZ66104, KZ66496, KZ66503, KZ66524,
KZ68568, KZ68718, KZ69426, KZ69429, KZ69432, KZ69437, KZ69440,
KZ69460, KZ69490, KZ69532, KZ69538, KZ70043, KZ70056, LP41656,
and LP41662;
c) Unit numbers GR27116, GR27918, GR29059, KA69384, KZ65237, KZ65377, KZ65392, KZ65396, KZ65399, KZ65456, KZ65471, KZ65534, KZ65623, KZ65751, KZ65770, KZ65793, KZ65803, KZ65826, KZ65886, KZ65902, KZ65922, KZ65971, KZ66011, KZ66170, KZ66178, KZ66182, KZ66191, KZ66197, KZ66199, KZ66216, KZ66242, KZ66243, KZ66249, KZ66265, KZ66269, KZ66273, KZ66276, KZ66282, KZ66286, KZ66287, KZ66288, KZ66326, KZ66332, KZ66334, KZ66345, KZ66348, KZ66359, KZ66362, KZ66368, KZ66370, KZ66375, KZ66401, KZ66403, KZ66405, KZ66406, KZ66415, KZ66417, KZ66431, KZ66433, KZ66435, KZ66449, KZ66450, KZ66451, KZ66457, KZ66459, KZ66464, KZ66465, KZ66467, KZ66493, KZ66494, KZ66497, KZ66509, KZ66549, KZ66559, KZ66561, KZ66571, KZ66578, KZ66598, KZ66603, KZ66050, KZ66607, KZ66621, KZ66622, KZ66628, KZ66636, KZ66637, KZ66660, KZ66688, KZ66809, KZ66814, KZ66822, KZ66827, KZ66829, KZ66839, KZ66840, KZ66844, KZ66852, KZ66856, KZ66858, KZ66860, KZ66868, KZ66873, KZ66888, KZ66896, KZ66929, KZ66967, KZ66979, KZ66982, KZ66996, KZ67010, KZ67016, KZ67027, KZ67035, KZ67041, KZ67053, KZ67078, KZ67080, KZ67141, KZ67148, KZ67157, KZ67199, KZ67238, KZ67259, KZ67277, KZ67310, KZ67410, KZ67428, KZ67431, KZ67436, KZ67438, KZ67443, KZ67459, KZ67462, KZ67477, KZ67486, KZ67499, KZ67503, KZ67529, KZ67600, KZ67637, KZ67650, KZ67716, KZ67718, KZ67721, KZ67723, KZ67724, KZ67747, KZ67771, KZ67782, KZ67825, KZ67840, KZ67853, KZ67896, KZ67904, KZ67910, KZ67916, KZ67918, KZ67919, KZ67931, KZ67937, KZ68118, KZ68126, KZ68127, KZ68129, KZ68149, KZ68179, KZ68180, KZ68195, KZ68201, KZ68207, KZ68257, KZ68275, KZ68276, KZ68314, KZ68316, KZ68319, KZ68329, KZ68340, KZ68362, KZ68367, KZ68369, KZ68394, KZ68411, KZ68412, KZ68429, KZ68452, KZ68518, KZ68532, KZ68556, KZ68561, KZ68599, KZ68615, KZ68623, KZ68624, KZ68625, KZ68675, KZ68677, KZ68702, KZ68712, KZ68719, KZ68724, KZ68725, KZ68729, KZ68732, KZ68736, KZ68741, KZ68747, KZ68770, KZ68782, KZ68835, KZ68836, KZ68844, KZ68847, KZ68857, KZ68889, KZ68922, KZ68940, KZ68976, KZ68986, KZ68992, KZ69006, KZ69039, KZ69051, KZ69061, KZ69073, KZ69074, KZ69076, KZ69079, KZ69091, KZ69143, KZ69190, KZ69193, KZ69200, KZ69211, KZ69229, KZ69243, KZ69268, KZ69298, KZ69306, KZ69342, KZ69366, KZ69373, KZ69383, KZ69401, KZ69408, KZ69412, KZ69562, KZ69639, KZ69647, KZ69663, KZ69746, KZ69768, KZ69829, KZ69842, KZ69844, KZ69847, KZ69854, KZ69863, KZ69882, KZ69897, KZ69939, KZ70114, KZ70133, KZ70137, LC15638, LE43800, LE43806, LE44451, LE45643, LE45645, LE45933, LE45942, LE45988, LE46000, LN54025, LN54033, LN54049, LN54514, LN54517, LN54520, LN54874, LN54884, LN54893, LN54894, LN55356, LN55373, LN55813, LN55817, LN55820, LN55824, LN55837, LN56255, LN56260, LN56267, LN56456, LN56671, LN56677, LN56683, LN56693, LN56729, LN58173, LN58188, LP44159, and T97635; and the following units were distributed as multiple split products. Units KZ66384, KZ67897, and LN55834 were distributed as three split products each, and unit KZ69402 was distributed as six split products;
d) Unit numbers KZ67073, KZ67246, KZ67542, KZ67838, KZ68331,
KZ68344, KZ68389, KZ68620, KZ68637, KZ68698, KZ68727,
KZ68906, KZ69002, LN56249, and LN56662
(all units distributed as two split products);
e) Unit numbers LN54033, LN54049, KZ66249, KZ66288, LN55813,
KZ68624, and KZ69342;
f) Pool numbers P18357, P18456, P18492, P24827, P24858, P24861,
P21772, P21898, P24750, P21700, P21735, P18210, P24583,
P24584, P24670, P24727, P24735, P21548, P21561, P21611,
P21624, P21727, P17562, P17664, P17709, P18168, P18242,
P18261, P18376, P18423, P24773, P24802, P24831, P24863,
P24897, P24927, P21755, P20011, P20018, P21659, P21512,
P18358, P24829, P24839, P18007, P21520, P24553, P24654,
P21672, P21740, P18028, P21570, P21675, P17574, P17545,
P21638, P18333, and P24837;
g) Unit numbers KZ67764, KZ69860, KZ69263, and KZ66488;
and unit number LH61515 was distributed as two split products;
h) Unit numbers KZ66888 and KZ66269;
i) Pool numbers P15517, P15578, P15615, P15654, P15717, P15733,
P19165, P19222, P22355, P22356, P22367, P22408, P22460, P23604,
P23622, P23663, P23675, P23683, and P27234;
j) Unit numbers KZ65297, KZ65534, KZ66929, KZ66637, KZ68319, KZ65392,
and KZ65399;
k) Unit numbers KZ65936 and KZ66296, and units KZ65203, KZ65311, KZ65323,
KZ65429, and KZ65666 were each distributed as three split products
l) unit numbers KZ66896, KZ67918, KZ68195, KZ68518, KZ68783, and KZ69091.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI by facsimile on February 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors that did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
495 units.
DISTRIBUTION
WI, VA, NY, LA, MS, FL, and IL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Source Plasma. Recall # B-0176-5.
CODE
Unit numbers CS0196618, CS0196815, CS0197266, CS0197481, CS0197946, CS0198192, CS0198601, CS0198845, CS0199280, CS0199485, CS0199899, CS0200158, CS0200569, CS0200802, CS0201186, and CS0201392.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX, by facsimile on September 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to recent surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0177-5.
CODE
Unit numbers CS0187466, CS0187895, CS0188275, CS0188657, CS0189089, CS0189434, CS0189903, CS0190273, CS0191103, CS0191504, CS0197565, CS0198006, CS0198267, CS0198685, CS0198925, CS0199427, CS0199640, CS0200867, and CS0201262.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX, by facsimile on April 11, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to recent surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced (2 units). Recall # B-0273-5;
b) Fresh Frozen Plasma [Apheresis). Recall # B-0274-5.
CODE
Unit number 1035847 (distributed as two split products);
Unit number 1035847.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letters on June 10, 2004, and August 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Fresh Frozen Plasma [Apheresis]. Recall # B-0276-5.
CODE
Unit numbers 15025-4907 and 15025-4922.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on February 24, 2004. Firm initiated recall is complete.
REASON
Blood products, possibly frozen more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0289-5.
CODE
Unit numbers LN54520, LN58188, KZ66170, KZ69268, KZ66191, KZ67931, KZ66216, KZ68421, KZ66242, LE45988, KZ66269, KZ69538, KZ66273, KZ66287, LP44159, KZ66288, KZ66282, KZ66345, KZ66359, KZ66362, KZ66370, KZ66375, KZ66379, KZ66401, LE45645, KZ65405, KZ66493, KZ68568, GR27918, KZ68624, KZ66243, KZ68712, KZ66660, KZ68724, KZ68729, KZ68732, KZ68736, KZ68747, KZ66766, KZ68836, LE43806, KZ68847, KZ66868, KZ65377, KZ67010, KZ68889, KZ66104, KZ68912, KZ68922, KZ68940, KZ68986, KZ66967, KZ68992, LN55824, LN55837, LC15638, KZ67477, KZ67486, KZ65793, KZ67499, KZ65786, KZ67503, KZ69401, KZ67600, KZ69829, KZ67637, KZ67721, KZ65770, KZ67723, KZ67747, KZ67771, KZ65471, KZ67842, LN56255, LN56260, LN56267, LN54520, LN58188, KZ67896, KZ67904, KZ67910, KZ68675, KZ69200, LN55356, LN55373, KZ66982, KZ67010, KZ68889, KZ67016, KZ69229, KZ67035, KZ65237, KZ67078, KZ67080, KZ69143, KZ67259, KZ69639, KZ67277, KZ67428, KZ67436, KZ67438, KZ67443, KZ69408, LN54025, LN55813, LN58173, LN55817, LN55820, KZ66406, KZ66417, KZ66418, KZ66431, KZ66433, KZ68275, KZ66435, KZ69476, KZ66450, KZ68257, KZ66451, KZ66457, KZ66459, KZ68725, LE45942, KZ66464, KZ66467, KZ66494, KZ66496, KZ68770, T97635, KZ66524, KZ66525, KZ66527, LN54884, LN56729, LN54893, KZ67141, KZ69006, LN56683, KZ69073, KZ66888, KZ69076, KZ69079, KZ67199, LP41656, KZ69193, KZ69211, KZ66688, KZ69243, KZ66549, KZ69373, KZ65751, KZ69383, KZ69412, KZ69426, KZ65456, KZ67310, KZ69429, KZ66852, KZ65826, KZ67529, LE44451, KZ69647, KZ67916, KZ68126, KZ68129, KZ66249, KZ68179, KZ66183, KZ68209, KZ68198, KZ66050, KZ68207, KZ68314, KZ68316, KZ66524, KZ66345, KZ66011, KZ68329, KZ68340, KZ68343, LE43800, LN54033, T93980, LN54049, LN56693, KZ68394, KZ65623, KZ68452, KZ67157, KZ69651, KZ69768, LN58198, KZ67027, KZ69844, KZ66979, KZ69847, KZ67044, KZ69849, KZ67782, KZ69854, KZ66334, KZ68127, KZ67459, KZ67716, KZ67724, KZ67650, LP41662, KZ67937, LN54894, KZ66561, KZ66571, KZ68380, KZ69051, KZ68392, KZ66603, KZ66607, KZ69074, GR29059, KZ68429, LE45933, KZ66639, KZ66809, KZ69061, KZ66814, KZ66827, KZ66829, KZ68976, LE46000, KZ66839, KZ66844, KZ66850, KZ66856, KZ68677, KZ66858, and KZ66860.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI by facsimile on February 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors that did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
235 units.
DISTRIBUTION
Switzerland.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Access AED (without audio record) Model Number: 9100-0100-0.
Recall # Z-0199-05;
b) Access AED Package (without audio record) Model Number: 9100-0150-0.
Recall # Z-0200-05;
c) Access AED (with audio record) Model Number: 9100-0100-1.
Recall # Z-0201-05;
d) Access AED Package (with audio record) Model Number: 9100-0150-1.
Recall # Z-0202-05;
e) Access ALS (Advanced Life Support) Model Number: 9100-0100-2.
Recall # Z-0203-05;
f) Access ALS Package Model Number: 9100-0150-2.
Recall # Z-0204-05;
g) Access AED PAD (without ECG trace) ‚Public Access Defibrillator
Model Number: 9100-0010-0. Recall # Z-0205-05;
h) Access AED PAD Package (without ECG trace) Model Number: 9100-0015-0.
Recall # Z-0206-06.
CODE
Serial Numbers: 075180 through 084760.
RECALLING FIRM/MANUFACTURER
Access Cardio Systems, Concord, MA, by letters on November 3, 2004. Firm initiated recall is ongoing.
REASON
Automated External Defibrillator device may fail to deliver shock due to a faulty circuit board.
VOLUME OF PRODUCT IN COMMERCE
8,636 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Electric Positioning Lift Chairs. Recall # Z-0212-05.
CODE
Model Numbers: C20, C30, GL358S, GL358L, TMR58, TMR540, TMR560, TMR570t, TMR571, TMR585, DMR670, TMR805, and TMR450.
RECALLING FIRM/MANUFACTURER
Pride Mobility Products Corp., Exeter, PA, by letter on May 14, 2004. Firm initiated recall is ongoing.
REASON
The heating pad on these Lift Chairs may tear at the entry point causing a short and/or overheating, which can damage the chair.
VOLUME OF PRODUCT IN COMMERCE
532 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Medtronic Midas Rex Legend Lubricant/Diffuser Cartridge Catalog number PA100-A. Recall # Z-0213-05.
CODE
A5972-V01; A5982-V01; A5991-V01; A5992-V01; A6308-V01through A6327-V01; A6666-V01 through A6684-V01; A6686-V01 through A6691-V01; A6919-V01 through A6934-V01; A7184-V01 through A7188-V01; A7194-V01through A7198-V01; A7495-V01 through A7501-V01; A7520-V01; A7521-V01; and A7525-V01.
RECALLING FIRM/MANUFACTURER
Power Surgical Solutions, Fort Worth, TX, by letter on November 3, 2004. Firm initiated recall is ongoing.
REASON
Reduced plastic thickness of lubricant/diffuser cartridge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
VOLUME OF PRODUCT IN COMMERCE
12,286 cases of 4 units per case.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity.
Cryosurgical Instrument Recall # Z-0215-05;
b) Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity.
Cryosurgical Instrument. Recall # Z-0216-05.
CODE
a) Serial numbers RP-10000 through RP-11060;
b) Serial numbers LP-10000 through LP-10951.
RECALLING FIRM/MANUFACTURER
Premier Dental Products Co., Plymouth Meeting, PA, by letters between May 2002 and March 2004. Firm initiated recall is ongoing.
REASON
Cryogen can escape from canister through the seal ring.
VOLUME OF PRODUCT IN COMMERCE
2,012 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box. Recall # Z-0214-05.
CODE
Lot 04027128 exp 2005-10.
RECALLING FIRM/MANUFACTURER
Zeus Scientific, Inc., Somerville, NJ, by telephone and letter on August 30, 2004. Firm initiated recall is complete.
REASON
During packaging, Lyme plates were packaged in this kit in error.
VOLUME OF PRODUCT IN COMMERCE
25 kits.
DISTRIBUTION
Nationwide and Israel.

_______________________________
PRODUCT
IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control. Recall # Z-0217-05.
CODE
Lot # 18220Q100 Exp. March 02, 2005.
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letters dated October 27, 2004. Firm initiated recall is ongoing.
REASON
IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.
VOLUME OF PRODUCT IN COMMERCE
397 kits.
DISTRIBUTION
Nationwide, PR, Canada, Germany, and Thailand.

END OF ENFORCEMENT REPORT FOR December 1, 2004

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