Roche recalls cobas infinity lab software versions 3.01.03 to 3.02.08 due to potential false positive or negative test results in specific user scenarios. Affected systems may need software updates to prevent incorrect lab results.
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
Roche is recalling specific versions of their cobas infinity lab software because it could show false positive or negative test results under certain conditions. This might lead to incorrect lab reports if not fixed, but the correct results are still available on the instrument.
Under specific user conditions, the software might replace test results with an automatic result sent to the lab system. This automatic result could be misinterpreted as a false positive or negative, though the correct result remains on the instrument.
Laboratories using Roche cobas infinity systems with software versions 3.01.03 through 3.02.08 are affected. Lab staff and users most at risk are those who rely on these systems for critical test results.
Check if your cobas infinity system has software versions 3.01.03 to 3.02.08. The catalog number 07154003001 or UDI 04015630936007 may also help identify affected units.
Verify your cobas infinity system's software version to see if it falls within 3.01.03 to 3.02.08.
The recall states that the correct results are still available on the instrument, but the automatic result could be misinterpreted by the lab system as a false positive or negative.
No, the recall does not require stopping use; the correct results remain available on the instrument.
The official recall does not specify a fix or remedy, so you may need to contact Roche for software updates or 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-2444-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-2444-2021 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.
