FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: 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.
- Recall number
- Z-1160-2008
- Recalling firm
- 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., Chaska, MN 55318.
- Status
- Terminated
- Initiated
- 2007-09-19
- Posted
- 2008-06-25
- Terminated
- 2012-05-09
- Reason
- False negative results when used to test serum samples (as compared to plasma samples).
- Root cause
- Other
- 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
- 8,205 units in the US; 332 in Canada
- Distribution
- Worldwide: including USA and Canada.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K953084"]
- PMA numbers
- not on file
- Product code
- CFP
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28