Z-1160-2008

Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle...

Name: Z-1160-2008 Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle...
Creator: Beckman Coulter Inc
Published: 2007-09-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-09-19 / Terminated

FDA source

Beckman Coulter Inc began a recall of Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative... on 2007-09-19. The reason FDA records is "False negative results when used to test serum samples (as compared to plasma samples)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1160-2008
Status: Terminated
Initiated: 2007-09-19
Posted: 2008-06-25
Terminated: 2012-05-09
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: CFP Radioimmunoassay, Immunoreactive Insulin
Reason for recall: False negative results when used to test serum samples (as compared to plasma samples).
FDA 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 in commerce: 8,205 units in the US; 332 in Canada
Distribution: Worldwide: including USA and Canada.
Product codes and lots: 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)

Product code CFP

K953084Class IAccess Ultrasensitive Insulin AssayBio-Rad Laboratories, Inc. / cleared 1995-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)