Roche recalls specific cobas infinity central lab software versions that may mismatch patient samples due to a configuration error. Affected units must be checked for specific settings.
A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.
Roche is recalling certain versions of its cobas infinity central lab software that could mismatch patient samples if configured incorrectly. This could lead to the wrong patient being associated with a sample, though it's rare and only happens under specific conditions.
The software bug causes sample orders to be mismatched with another patient's ID when the sample's barcode date doesn't match the order date from the laboratory system. This happens only under rare conditions where specific configuration settings are active.
Laboratories using Roche cobas infinity central lab software versions 2.5.x, 3.01.x, 3.02.x, or 3.03.x with specific configuration settings are affected. Those in the U.S. are less likely to be impacted due to common configuration practices.
Check if your cobas infinity central lab software is version 2.5.x, 3.01.x, 3.02.x, or 3.03.x and has been configured with the four specific pre-conditions listed in the recall notice.
Verify if your cobas infinity central lab software meets the four specific configuration pre-conditions described in the recall notice.
No, the recall specifically targets configurations uncommon in U.S. labs, so most U.S. laboratories are not affected.
Check if your cobas infinity central lab software is version 2.5.x, 3.01.x, 3.02.x, or 3.03.x and has been configured with all four specific pre-conditions listed in the recall notice.
No, if your software does not meet the specific configuration pre-conditions, it is not affected by this recall.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0952-2023 — Roche Roche Hello, I own a Roche that is covered by recall Z-0952-2023 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.
