Roche recalls Cobas Infinity software versions 2.0-2.5 for potential QC alarm failures when switching bottles in clinical lab use. Affected units include specific serial numbers and material numbers.
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Roche is recalling certain versions of its Cobas Infinity software (2.0 through 2.5) because quality control alarms may not display when switching between sample bottles. This could lead to undetected out-of-range quality control results, potentially affecting lab accuracy.
When the software switches from a standby bottle to a current bottle, quality control alarms may not show if the standby bottle's quality control is out of range. This could result in undetected errors in lab testing.
Clinical laboratory users with the specific software versions and serial numbers listed in the recall notice. Lab technicians and staff handling samples are most at risk of inaccurate results.
Check if your Cobas Infinity system has software versions 2.0 through 2.5. Affected units include specific serial numbers: 81191, 81371, 81385, 81465, 81469, 81470, 81481, 81485, 81527, 81528, 81618, 81628, 81652, 81655, 81662.
Verify your Cobas Infinity software version is 2.0 through 2.5.
Using software versions 2.0 through 2.5 with the Standby bottle function may cause quality control alarms to not display when switching bottles, potentially leading to undetected out-of-range results.
The recall does not specify a remedy, so contact Roche Diagnostics Corporation directly for guidance.
Serial numbers: 81191, 81371, 81385, 81465, 81469, 81470, 81481, 81485, 81527, 81528, 81618, 81628, 81652, 81655, 81662.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1368-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1368-2019 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.
