FDA Device recall Z-1596-2021
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction
- FDA Device
- Class II
- ongoing
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1596-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-07 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
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.
Identifiers
| code_info | UDI: 04015630939374 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1596-2021%22
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