Roche Diagnostics Operations, Inc. Recall 87705
Description: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Roche Diagnostics Operations, Inc. Recall 87705 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1595-2021 |
| Event ID | 87705 |
| Event Description | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. |
| Product Type | Devices |
| 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. |
| Quantity | 10, 489 kits |
| Recall 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. |
| Device Classification | 20210526 |
| Device Code Info | UDI: 04015630939381 |
| Center Classification Date | 20210514 |
| Recall Initiation Date | 20210407 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | FAX |
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