Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, I
FDA device recall Z-1147-03 · posted 2003-08-21 · Terminated
Recall details
- Recalling firm
- Zeus Scientific Inc
- Reason for recall
- Bacterial contamination of the high positive control.
- Action taken
- Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 130
- Distribution
- All product was shipped to St. Louis, MO
- Date initiated
- 2001-06-22
- Date posted
- 2003-08-21
- Date terminated
- 2003-08-20
- Location
- Branchburg, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM (K984173) | Zeus Scientific, Inc. | 1998-12-22 |