Elecsys Troponin I Immunoassay: Catalog# 05094810160 -… recallZ-1596-2021 · Roche Diagnostics Operations, Inc. · initiated Apr 7, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1596-2021
- Status
- Open, Classified
- Initiated by the company
- Apr 7, 2021
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 726 kits
- Product code
- MMI
- FDA submissions
- K082699
- 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.
Product description
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Code information (models, lots, serial numbers)
UDI: 04015630939374
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Elecsys Troponin I Immunoassay 5094810160Roche Diagnostics GmbH · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall2 reports
Other devices under the same FDA submission
2 devices cleared under K082699 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Elecsys Troponin I STAT Immunoassay 5094798160Roche Diagnostics GmbH · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall3 reports
- Elecsys Troponin T STAT Assay 4660307190Roche Diagnostics GmbH · IMMUNOASSAY METHOD, TROPONIN SUBUNIT6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 87705).
- Z-1595-2021 · Open, ClassifiedElecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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