Roche recalls Omni S2 analyzers with catalog numbers 3337111001 and 3337111692 due to software failure preventing scheduled AutoQC measurements from activating.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Roche is recalling specific Omni S2 analyzers that have a software issue preventing scheduled AutoQC measurements from starting. This could lead to inaccurate test results if the system doesn't properly check its calibration.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. This means the analyzer may not properly check its calibration at regular intervals, potentially leading to inaccurate test results if the system is not functioning correctly.
Laboratories using Roche Omni S2 analyzers with catalog numbers 3337111001 or 3337111692 are affected. Lab technicians and clinical staff who rely on these analyzers for critical blood tests are most at risk.
Check for catalog numbers 3337111001 or 3337111692 on the Roche Omni S2 analyzer. The product was sold with a unique device identifier (UDI) starting with 04015630018307.
Verify if scheduled AutoQC measurements are starting as expected by reviewing the analyzer's logs.
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate, which could lead to inaccurate test results if the system does not properly check its calibration.
The recall does not specify a remedy, so you should check if scheduled AutoQC measurements are starting as expected and contact Roche for further guidance.
Yes, catalog numbers 3337111001 and 3337111692 are affected.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1610-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1610-2018 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.
