Roche recalls Omni S Analyzer models 3337138001 and 3337138692 due to software failure preventing scheduled AutoQC measurements. Affected units may not properly check instrument calibration.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Roche is recalling two specific models of their Omni S Analyzer blood testing machines because the software fails to start scheduled quality control checks. This could lead to inaccurate test results if the machine isn't properly calibrated.
The software that schedules automatic quality control tests won't activate, meaning the machine might not check its calibration properly. This could lead to inaccurate test results if the machine isn't calibrated correctly.
Healthcare facilities using Roche Omni S Analyzer models 3337138001 and 3337138692 for blood testing are most at risk. Patients using these machines for critical care tests may experience inaccurate results.
Check for catalog numbers 3337138001 or 3337138692 on the machine's label. The device is a blood testing analyzer used in healthcare settings.
Verify if the AutoQC measurements are starting as scheduled in the machine's software interface.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate, which could lead to inaccurate test results if the machine isn't properly calibrated.
The affected models are catalog numbers 3337138001 and 3337138692.
No, the recall does not require immediate discontinuation. Users should check if AutoQC measurements are starting as scheduled.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1611-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1611-2018 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.
