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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 Device Recall Access Ultrasensitive Insulin Assay Kitsee related information
Date Initiated by FirmSeptember 19, 2007
Date PostedJune 25, 2008
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-1160-2008
Recall Event ID 45955
510(K)NumberK953084 
Product Classification Insulin Assay in-vitro diagnostic kit - Product Code CFP
ProductAccess 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 CA 92822-6208
For Additional Information ContactNora 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		Other
ActionOn 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 Commerce8,205 units in the US; 332 in Canada
DistributionWorldwide: including USA and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CFP
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