Recall Z-1160-2008 ยท CFP Radioimmunoassay, Immunoreactive Insulin
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.
| Date | Jun 25, 2008 (initiated Sep 19, 2007) |
| Status | Terminated |
| 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 othe |
| Quantity | 8,205 units in the US; 332 in Canada |
| Distribution | Worldwide: including USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953084 | ACCESS ULTRASENSITIVE INSULIN ASSAY Bio-Rad Laboratories, Inc., Sep 25, 1995 |