| | Class 2 Recall
Access Ultrasensitive Insulin Assay Kit |  |
| Date Posted |
June 25, 2008 |
| Recall Number |
Z-1160-2008 |
| Product |
Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, MN 55318. |
| Code Information |
Part Number 33410, Lot Numbers: 714362 (Exp dt. 3/31/09), 716129 (Exp dt. 6/30/09), 718258 (Exp dt. 7/31/09), 519096 (Exp dt. 10/31/07), 521487 (Exp dt. 2/28/08), 616274 (Exp dt. 7/31/08), 617890 (Exp dt. 7/31/08), 617891 (Exp dt. 7/31/08) and 620204 (Exp dt. 12/31/08)
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Recalling Firm/
Manufacturer |
Beckman Coulter Inc
200 S Kraemer Blvd
Brea, California 92822-6208 |
| For Additional Information Contact |
Nora Zerounian
714-961-3634 Ext. 8383
|
Reason for
Recall |
False negative results when used to test serum samples (as compared to plasma samples).
|
| Action |
On September 19, 2007, Beckman Coulter mailed to its consignees an Urgent Product Corrective Action Letter informing them that the affected lots of the product were giving false negative results when used to test serum samples (as compared to plasma samples). The letter instructed consignees to discontinue using the affected lots of the product, and to re-test using an EDTA plasma sample if there was any discordance between the results of the serum sample (if it was obtained using an affected lot of the product) as compared with the clinical presentaion of the patient and the results of other diagnostic tests. The letter also instructed consignees to return, within 10 days, the Response Sheet . |
| Quantity in Commerce |
8,205 units in the US; 332 in Canada |
| Distribution |
Worldwide: including USA and Canada. |
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