Roche recalls Elecsys Troponin I Immunoassay (Catalog# 05094810160) due to possible false negative results in heart tests when used with specific cobas e601/e602 modules. Affected users should contact Roche for details.
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 a heart test kit that may give false negative results when used with certain lab equipment. This could lead to missing heart attacks if the test is run incorrectly. The recall affects labs using specific models of the test kit.
The test may show a lower result for Troponin I when run immediately after proBNP II on the same lab module. This could cause false negatives, meaning a heart attack might not be detected properly.
Labs using Roche's Elecsys Troponin I Immunoassay (Catalog# 05094810160) with cobas e601 or e602 modules are affected. Lab technicians and medical staff who run these tests are most at risk.
Check for the catalog number 05094810160 on the test kit. The product is used in labs with cobas e601 or e602 modules for heart tests.
Reach out to Roche Diagnostics for specific instructions on the recall and next steps.
The recall does not mention any risk of serious injury. The hazard is possible false negatives in heart tests.
Look for the catalog number 05094810160 on the test kit. It is used with cobas e601 or e602 modules for heart tests.
The recall does not require immediate stop use. Contact Roche for specific instructions.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1596-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-1596-2021 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.
