Recall Z-0950-03 ยท MID System, Test, Anticardiolipin Immunological
Binding Site Inc The
Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029
| Date | Jun 21, 2003 (initiated Mar 27, 2003) |
| Status | Terminated |
| Reason | Risk of false positives. |
| Root cause | Other |
| Action | Recall notice was sent by fax March 27, 2003. The recall is complete. |
| Quantity | 239 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983694 | ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd., Feb 5, 1999 |