Elecsys Troponin I Immunoassay: Catalog# 05094810160 — Class II medical device recall Z-1596-2021
Ongoing recall by Roche Diagnostics Operations, Inc., reported 2021-05-26, distributed nationwide. Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue
| Recall number | Z-1596-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2021-04-07 |
| Classified | 2021-05-14 |
| Reported by FDA | 2021-05-26 |
| Distributed | Nationwide (US) |
| Quantity | 726 kits |
| UPC / GTIN / UDI-DI | 04015630939374 |
| Model numbers | 05094810160 |
Product
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1596-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.