Roche recalls vancomycin testing devices that may give low sample results. Affected units include cobas c 311 and cobas c 501/502 analyzers with catalog # 06779336190.
Inaccurately Low Sample Results
Roche is recalling vancomycin testing devices that may give inaccurate low results. This could lead to incorrect treatment decisions for infections.
The devices may produce test results that are too low, potentially leading to underdosing of vancomycin. This could result in ineffective treatment of infections.
Healthcare professionals using the cobas c 311 or cobas c 501/502 analyzers for vancomycin testing. Patients receiving treatment based on these devices may be at risk of incorrect dosing.
Check for the catalog number 06779336190 on the device. The affected models are cobas c 311 and cobas c 501/502 analyzers used for vancomycin testing.
Look for the catalog number 06779336190 on the cobas c 311 or cobas c 501/502 analyzer.
The recall does not require stopping use; it is a low-risk issue with potential for inaccurate results.
Check for the catalog number 06779336190 on the cobas c 311 or cobas c 501/502 analyzer.
The recall does not specify a remedy, so contact Roche for further guidance.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0042-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-0042-2020 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.
