Recall Z-1596-2021 ยท MMI Immunoassay Method, Troponin Subunit
Roche Diagnostics Operations, Inc.
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
| Date | Apr 7, 2021 |
| Status | Open, Classified |
| Reason | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed. |
| Root cause | Device Design |
| Action | On 04/07/2021, Roche issued Urgent Medical Device Correction via fax notifying customers that Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/ proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte was measured immediately before the Troponin I analyte on the same module, a decreased recovery of Troponin I was observed. |
| Quantity | 726 kits |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, ID, IL, IN,KS, KY, MD, ME, MO, NC, NE, NJ, NM, NY, OH, OK, SC, SD, TN, TX, VA, WA, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082699 | ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS Roche Diagnostics, Aug 19, 2009 |