Recall Z-0835-06 ยท MID System, Test, Anticardiolipin Immunological
Thera Test Laboratories, Inc.
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148
| Date | May 4, 2006 (initiated Jan 11, 2006) |
| Status | Terminated |
| Reason | The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204. |
| Root cause | Other |
| Action | On 10/26/05, Thera Test telephoned the 3 accounts who received lot 09055514 without the Data Sheet in the kits, and sent them copies of the Data Sheet for insertion into the 6 kits on hand at the consignees. Between 1/4-9/06, Thera Test telephoned the 17 accounts receiving kit lots 09055514 and 12055603, and sent them follow-up letters dated 1/9/06 with replacement bottles of Specimen Diluent. The accounts were advised of the fungal contamination found in some bottles of the diluent shipped with the kit lots, and were requested to destroy any remaining bottles of the Specimen Diluent in thei |
| Quantity | 53 kits |
| Distribution | California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA Theratest Laboratories, Inc., Feb 7, 2006 |