DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardio
FDA device recall Z-0632-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
- Action taken
- Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.
- Root cause
- Other
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 16 kits
- Distribution
- GA, NY & KS
- Date initiated
- 2004-01-23
- Date posted
- 2005-03-18
- 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 |