Roche recalls Cobas Infinity calculators for clinical use due to a software error that may remove serum indices flags, risking unreliable test results. Affected units include all versions from cobas infinity 3.00.0:00 onwards.
A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
Roche is recalling Cobas Infinity calculators used in labs because a software error can cause them to skip a quality check for blood samples. This might lead to incorrect test results being reported without warning.
The calculator normally flags results that need serum quality checks (like hemolysis or lipemia). A software error can remove this flag, causing unreliable results to be reported without a warning about poor sample quality.
Healthcare providers using the Cobas Infinity calculator for lab testing are likely affected. Those handling blood samples without the serum indices check could be at risk of receiving inaccurate results.
Check for the catalog number 07154003001 on the device. Affected units are all versions of the Cobas Infinity calculator from software version 3.00.00 onwards.
Look for the catalog number 07154003001 and software version 3.00.00 or later on the device.
The software error causes the serum indices flag to be incorrectly removed, which may lead to unreliable test results being reported without a warning about poor sample quality.
Check for the catalog number 07154003001 and software version 3.00.00 or later on the device.
No action is needed if your calculator has a software version earlier than 3.00.00 or does not have the catalog number 07154003001.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0883-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0883-2021 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.
