Recall Z-0870-03 ยท MMI Immunoassay Method, Troponin Subunit
Roche Diagnostics Corp.
Elecsys Troponin T; catalog number 2017644
| Date | May 29, 2003 (initiated Apr 25, 2003) |
| Status | Terminated |
| Reason | Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results. |
| Root cause | Other |
| Action | An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL. |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984105 | ELECSYS TROPONIN T STAT TEST Boehringer Mannheim Corp., Dec 8, 1998 |