Roche recalls Elecsys Troponin I STAT Immunoassay (Catalog# 05094798160) due to possible false negatives in heart attack tests when used with specific analyzers. Affected units may not detect heart attacks correctly.
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.
Roche is recalling its Elecsys Troponin I STAT Immunoassay test kit because it can sometimes give false negative results for heart attacks when used with certain lab analyzers. This means the test might miss a heart attack if the patient is actually having one.
The test kit can produce false negative results when the proBNP II test is run immediately before the Troponin I test on the same analyzer module. This means the test might not detect a heart attack if the patient is having one.
Lab technicians using Roche's Elecsys Troponin I STAT test kit with cobas e 601 or 602 analyzers are most at risk. Patients undergoing heart attack tests using this specific kit could potentially miss their diagnosis.
Check for the catalog number 05094798160 on the test kit. The product is used with cobas e 601 or 602 analyzers for heart attack testing.
Look for the catalog number 05094798160 on the test kit label.
Roche has confirmed that the Elecsys Troponin I STAT test kit can sometimes give false negative results for heart attacks when used with specific analyzers, meaning it might miss a heart attack.
The recall record does not specify a remedy, so no action is required beyond checking the catalog number.
The recall indicates a potential risk of missing a heart attack diagnosis, but the hazard level is low risk as it only affects test accuracy in specific lab conditions.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1595-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-1595-2021 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
