Recall Z-0632-05 ยท MID System, Test, Anticardiolipin Immunological
Diasorin Inc.
DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
| Date | Mar 18, 2005 (initiated Jan 23, 2004) |
| Status | Terminated |
| Reason | DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits. |
| Root cause | Other |
| Action | Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced. |
| Quantity | 16 kits |
| Distribution | GA, NY & KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001981 | DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 Axis-Shield , Ltd., Aug 21, 2000 |