DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Sti
FDA device recall Z-0927-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).
- Action taken
- Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered.
- Root cause
- Other
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 49
- Distribution
- NY, KS, GA & MT
- Date initiated
- 2004-11-01
- Date posted
- 2005-06-25
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 (K001981) | Axis-Shield , Ltd. | 2000-08-21 |