Roche recalls Cobas Infinity lab software versions 2.4.1 to 2.5.4 due to incorrect alarm mapping that could lead to missed clinical alerts.
Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
Roche is recalling specific versions of its Cobas Infinity lab software because they have a bug that might cause alarms to be mapped incorrectly. This could lead to missed critical clinical alerts in laboratory settings.
The software versions have a bug that causes alarms to be mapped incorrectly. This could result in critical clinical alerts being missed, potentially affecting patient safety. However, the risk is contained to the software's internal logic and not a physical hazard.
Laboratory staff using Roche Cobas Infinity software versions 2.4.1 through 2.5.4 for clinical testing are most at risk. The recall affects healthcare facilities that use this specific software version.
Check if you have Cobas Infinity software versions 2.4.1 to 2.5.4. The product is used in clinical laboratory settings and is part of Roche's Cobas Infinity system.
Verify your Cobas Infinity software version by checking the software's version number in the system settings.
The recall is for a software bug that could cause missed clinical alerts, but it does not pose an immediate physical hazard. The risk is low and specific to the software version.
Check your Cobas Infinity software version; the recalled versions are 2.4.1 through 2.5.4.
No, you do not need to stop using the software immediately. However, you should check your version and consider updating to a newer version if available.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0922-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-0922-2020 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.
