Roche recalls cobas e 601 modules for clinical use due to potential inaccurate test results when 13 sample tubes are used without adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Roche is recalling certain cobas e 601 modules for clinical use because using 13 sample tubes without adapters can cause questionable test results. This affects healthcare facilities that use these modules for lab testing.
The hazard occurs when 13 sample tubes are used without the required adapters. This can lead to questionable test results, meaning lab results might not be accurate for patient care.
Healthcare facilities using the recalled cobas e 601 modules for clinical testing are most at risk. Patients receiving tests from these facilities could get inaccurate results if the issue occurs.
Check for cobas e 601 modules with catalog numbers 04745922001, 05036348001, 05860652001, 04745922692, or 05036348692. These were sold for clinical use in the U.S. and Canada.
Ensure you have the correct tube adapters for 13 sample tubes before use.
Roche received complaints about questionable test results when 13 sample tubes were used without tube adapters.
The recall record does not specify a remedy, so contact Roche directly for guidance.
The hazard is limited to potential inaccurate test results, not physical harm.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1268-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1268-2018 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.
