Roche recalls cobas c 111 analyzers used for creatinine and triglyceride tests due to carry-over risk. Affected units may need extra wash cycles or batch mode for accurate results.
COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
Roche is recalling cobas c 111 analyzers used for creatinine and triglyceride tests because of a carry-over issue that could affect test accuracy. This means results might be incorrect if extra wash cycles or batch mode aren't used.
The analyzers may have carry-over issues where previous test results contaminate the next test. This can lead to inaccurate results for creatinine and triglyceride tests if extra wash cycles or batch mode aren't used.
Lab users who operate Roche cobas c 111 analyzers for creatinine and triglyceride tests are affected. Those handling the specific test kits with catalog numbers 05401470190 and 04657594190 are most at risk.
Check if your Roche cobas c 111 analyzer is used for creatinine plus ver.2 (catalog 05401470190) or triglycerides (catalog 04657594190). The device is part of a lipoprotein test system for serum and plasma.
Ensure your analyzer uses extra wash cycles for creatinine and triglyceride tests to prevent carry-over.
Confirm batch mode is active for specific tests to avoid carry-over errors.
The recall is for carry-over issues that could cause inaccurate creatinine and triglyceride test results if extra wash cycles or batch mode aren't used.
Catalog numbers 05401470190 for creatinine plus ver.2 and 04657594190 for triglycerides.
No, you can continue using it as long as you follow extra wash cycles or batch mode for the affected tests.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1125-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1125-2019 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.
