Recalling Firm / Manufacturer

Beckman Coulter Inc

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.

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)

Reason of Recall

False negative results when used to test serum samples (as compared to plasma samples).

Date Recall Initiated

September 19, 2007

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 .

Contact

Al-Jeel Medical & Trading Co. limited
Riyadh
(01) 4041717

Source of Information

U.S.FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.