Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029
FDA device recall Z-0950-03 · posted 2003-06-21 · Terminated
Recall details
- Recalling firm
- Binding Site Inc The
- Reason for recall
- Risk of false positives.
- Action taken
- Recall notice was sent by fax March 27, 2003. The recall is complete.
- Root cause
- Other
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 239
- Distribution
- Nationwide.
- Date initiated
- 2003-03-27
- Date posted
- 2003-06-21
- Date terminated
- 2004-12-01
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT (K983694) | The Binding Site, Ltd. | 1999-02-05 |