Recall Z-0782-04 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Laboratories HPD/ADD/GPRD
AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
| Date | Jul 20, 2004 (initiated Mar 26, 2004) |
| Status | Terminated |
| Reason | An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction. |
| Root cause | Other |
| Action | Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory. |
| Quantity | 7,394 kits |
| Distribution | Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, Taiwan, Australia, New Zealand, Thailand, China and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974103 | ABBOTT AXSYM TROPONIN-I Abbott Laboratories, Nov 25, 1997 |