Roche recalls cobas c 311 and cobas c 501/502 analyzers for inaccurate vancomycin test results. All units with catalog # 06779344190 are affected.
Inaccurately Low Sample Results
Roche is recalling its cobas c 311 and cobas c 501/502 analyzers for vancomycin tests because they may give inaccurate low results. This could lead to incorrect dosing decisions for patients needing vancomycin treatment.
The analyzers may produce vancomycin test results that are too low. This could lead to under-dosing patients, potentially causing treatment failure or adverse effects.
Healthcare facilities using Roche's cobas c 311 or cobas c 501/502 analyzers for vancomycin testing are affected. Patients receiving vancomycin treatment via these analyzers may be at risk of incorrect dosing.
Check for the catalog number 06779344190 on the analyzer or module. The product includes the cobas c 311 and cobas c 501/502 analyzers.
Look for the catalog number 06779344190 on the analyzer or module.
The analyzers may produce vancomycin test results that are too low, which could lead to under-dosing patients.
Check for the catalog number 06779344190 on the analyzer or module. If you have the product, contact Roche for further instructions.
The recall is for inaccurate test results, not a direct safety hazard. There is no mention of serious injury risk in the official notice.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0043-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-0043-2020 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.
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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.
