Recall Z-1147-03 ยท MID System, Test, Anticardiolipin Immunological
Zeus Scientific Inc
Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
| Date | Aug 21, 2003 (initiated Jun 22, 2001) |
| Status | Terminated |
| Reason | Bacterial contamination of the high positive control. |
| Root cause | Other |
| Action | Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory. |
| Quantity | 130 |
| Distribution | All product was shipped to St. Louis, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984173 | THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM Zeus Scientific, Inc., Dec 22, 1998 |