Recall Z-0214-05 ยท MID System, Test, Anticardiolipin Immunological
Zeus Scientific Inc
Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also place
| Date | Nov 20, 2004 (initiated Aug 30, 2004) |
| Status | Terminated |
| Reason | During packaging, Lyme plates were packaged in this kit in error. |
| Root cause | Other |
| Action | Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand. |
| Quantity | 25 kits |
| Distribution | 25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. There were no ships to government facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981021 | ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM Zeus Scientific, Inc., Jun 2, 1998 |