Roche recalls homocysteine test kits for cobas c701/702 systems due to calibration failures. Affected lots may give inaccurate results. Contact Roche for details.
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Roche is recalling homocysteine test kits used with cobas c701 and c702 analyzers because they may have calibration issues. This could lead to inaccurate test results, which might affect medical diagnoses.
The test kits may have calibration failures, leading to inaccurate results for homocysteine levels. This could affect medical diagnoses for conditions like hyperhomocysteinemia or homocystinuria.
Healthcare professionals using Roche homocysteine test kits with cobas c701 or c702 analyzers. Patients receiving tests with these kits may be at risk of inaccurate results.
Check for the catalog number 06542921190 on the test kit. The lot number 422313 and expiration date 07/31/2020 are also associated with this recall.
Look for the catalog number 06542921190 and lot number 422313 on the test kit.
Roche is recalling homocysteine test kits used with cobas c701 and c702 analyzers due to potential calibration failures.
Check for the catalog number 06542921190 and lot number 422313 on the test kit.
The recall does not specify a remedy, so contact Roche directly for guidance.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0679-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-0679-2020 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.
