Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent imm
FDA device recall Z-1160-2008 · posted 2008-06-25 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- False negative results when used to test serum samples (as compared to plasma samples).
- Action taken
- 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 .
- Root cause
- Other
- Status
- Terminated
- Product code
- CFP
- Quantity affected
- 8,205 units in the US; 332 in Canada
- Distribution
- Worldwide: including USA and Canada.
- Date initiated
- 2007-09-19
- Date posted
- 2008-06-25
- Date terminated
- 2012-05-09
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084) | Bio-Rad Laboratories, Inc. | 1995-09-25 |