Recall Z-0927-05 ยท MID System, Test, Anticardiolipin Immunological
Diasorin Inc.
DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.
| Date | Jun 25, 2005 (initiated Nov 1, 2004) |
| Status | Terminated |
| Reason | DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL). |
| Root cause | Other |
| Action | Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered. |
| Quantity | 49 |
| Distribution | NY, KS, GA & MT |
| 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 |