Recall Z-1660-2022 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Laboratories
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
| Date | Jul 26, 2022 |
| Status | Open, Classified |
| Reason | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. |
| Root cause | Under Investigation by firm |
| Action | On July 26, 2022, Abbott issued a Product Recall letter for this issue sent the letter via FedEx priority overnight express. The letter provided the reason for the recall and hazard involved and requested the consignee take the following actions: "" IMMEDIATELY discontinue use of ARCHITECT STAT Troponin-I, List Number 2K41-27 lot number 63718UN22 and destroy all inventory of lot 63718UN22 according to your laboratory procedures. " Please contact Customer Support to order replacement material. " Please review this letter with your Medical Director or Laboratory Management and follow your labor |
| Quantity | 2451 kits of 100 tests |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY Fisher Diagnostics, Aug 12, 2004 |