Roche recalls Omni S6 analyzers with catalog numbers 3337154001 and 3337154692 due to software failure preventing scheduled AutoQC measurements. This may affect lab accuracy.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Roche is recalling certain Omni S6 analyzers because the software that starts routine quality control tests doesn't activate. This could lead to inaccurate lab results if the system isn't properly maintained.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. This means the analyzer may not run necessary quality checks on its own, potentially leading to inaccurate test results over time.
Lab users with the specific catalog numbers 3337154001 or 3337154692 are affected. Healthcare facilities using these analyzers for critical blood tests are most at risk.
Check for catalog numbers 3337154001 or 3337154692 on the device. The Roche Diagnostics Omni S Analyzer is a critical care blood testing device used in labs.
Verify if the AutoQC measurements start automatically as per the device's schedule.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate, which could lead to inaccurate lab results.
Catalog numbers 3337154001 and 3337154692.
No immediate stop is required; the remedy is not specified in the recall notice.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1612-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1612-2018 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.
