Roche recalls cobas infinity software versions 3.00.00+ for potential incorrect lab results due to QC status errors. Affected units include specific serial numbers listed in the recall notice.
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Roche is recalling certain versions of their cobas infinity software for lab systems. The software may incorrectly validate lab results if a quality control status expiration rule is mishandled, which could lead to inaccurate test outcomes.
The software may incorrectly validate lab results when a quality control status expiration rule is not handled properly. This could lead to inaccurate test outcomes if the system misinterprets the quality control status of lab samples.
Lab users with the specific cobas infinity software versions and serial numbers listed in the recall notice are affected. Healthcare professionals using these systems for lab testing may be at risk of inaccurate results.
Check if your cobas infinity software version is 3.00.00 or newer. Look for the specific serial numbers listed in the recall notice (e.g., 82014, 82229, etc.).
Verify your cobas infinity software version is 3.00.00 or newer.
Check if your device has a serial number listed in the recall notice (e.g., 82014, 82229, etc.).
The recall is for potential incorrect validation of lab results due to an erroneous QC status when using the status expiration control rule.
Software versions from cobas infinity version 3.00.00 onwards.
Check your software version and serial number against the list provided in the recall notice.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0461-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0461-2021 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.
