Roche recalls cobas infinity core calculator modules for clinical use where alarm flags with < symbol don't display on validation screen. All software versions affected.
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
Roche is recalling cobas infinity core calculator modules used in clinical labs because alarm flags with a < symbol don't show on the validation screen. This affects lab users doing manual validation. The issue could lead to missed alarms during testing.
The alarm flags with a < symbol don't appear on the validation screen during manual testing. This means critical alerts might be missed, potentially affecting test results. The issue only occurs when users manually validate tests.
Lab technicians and clinical staff using the cobas infinity system for manual validation. Those with the specific software version are most at risk.
Check if your cobas infinity core module has Material No. 7154003001. All cobas infinity laboratory software versions are affected.
Identify if your cobas infinity core has Material No. 7154003001.
Confirm your cobas infinity software version is affected by all versions.
The alarm flags with a < symbol don't display on the cobas infinity Validation screen during manual validation, which could lead to missed alerts.
The recall record does not mention a remedy or fix.
Check if your cobas infinity core has Material No. 7154003001. All cobas infinity laboratory software versions are affected.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1158-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-1158-2020 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.
