Roche recalls cobas HCYS Homocysteine Assay (Material REF 06542921190) for potential erroneous patient test results. Affected units sold with cobas c 701/702 devices.
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Roche is recalling its cobas HCYS Homocysteine Enzymatic Assay to prevent inaccurate blood test results. This could lead to incorrect health diagnoses if used without the recall fix.
The assay can give wrong test results due to calibration issues, which might show too high or too low homocysteine levels. This could lead to incorrect health decisions if the test is used without the recall fix.
People who use the cobas HCYS assay with Roche cobas c 701/702 devices for homocysteine blood tests. Those with recent test results may be at risk of incorrect health conclusions.
Check for the Material Number REF 06542921190 on the cobas HCYS assay. The assay is sold with cobas c 701/702 devices for homocysteine blood tests.
Look for the Material Number REF 06542921190 on the cobas HCYS assay label.
The assay can produce erroneous patient results due to abnormal calibration signals and control recovery issues.
The recall record does not specify a remedy, so check with Roche for guidance.
The recall is for potential inaccurate test results, not immediate safety risks. The danger level is low risk.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0489-2025 — Roche Roche Hello, I own a Roche that is covered by recall Z-0489-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
