Recall Z-0782-03 ยท JLS Radioimmunoassay, Progesterone
Abbott Laboratories HPD/ADD
Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
| Date | Apr 24, 2003 (initiated Mar 31, 2003) |
| Status | Terminated |
| Reason | Lot gives lower specimen results compared to results generated with other lots. |
| Root cause | Other |
| Action | Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management. |
| Quantity | 368 kits |
| Distribution | Nationwide, Canada, Columbia, England, Japan, Australia, New Zealand and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.