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U.S. Department of Health and Human Services

Class 2 Device Recall Access Ultrasensitive Insulin Assay Kit

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 Class 2 Recall
Access Ultrasensitive Insulin Assay Kit
see related information
Date Posted June 25, 2008
Recall Status1 Open
Recall Number Z-1160-2008
Recall Event ID 45955
Premarket Notification
510(K) Number
K953084 
Product Classification Radioimmunoassay, Immunoreactive Insulin - Product Code CFP
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)
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
Manufacturer Reason
for Recall
False negative results when used to test serum samples (as compared to plasma samples).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CFP and Original Applicant = BIO-RAD LABORATORIES, INC.
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