Siemens Healthcare recalls Atellica CH 930 analyzers with software version 1.13 or lower due to 5 potential issues affecting reagent locks, sample reading, and test results.
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
Siemens Healthcare is recalling Atellica CH 930 analyzers with software version 1.13 or older because they may have five specific problems that could lead to incorrect test results or failed tests. This affects medical labs that use these analyzers for diagnostic testing.
The software issues could cause reagent locks to malfunction, sample barcodes to be misread, certain tests to fail, and reporting units to stay incorrect after changes. These problems might lead to inaccurate test results if multiple reagent lots are used or specific dilutions are ordered.
Medical laboratories using Siemens Atellica CH 930 analyzers with software version 1.13 or lower are most at risk. These analyzers are used for in vitro diagnostic testing of clinical specimens.
Check for the Atellica CH 930 Analyzer with software version 1.13 or lower. This model is sold under the Siemens Healthcare brand for in vitro diagnostic testing.
Contact Siemens Healthcare to get the latest software version for the Atellica CH 930 Analyzer.
Software version 1.13 and lower.
Five issues: reagent locks may not work with multiple reagent lots, sample barcodes may be misread, certain tests may fail, reporting units may stay incorrect, and results may not display for auto-diluted samples.
No, but you should update the software to the latest version to fix the issues.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0194-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0194-2019 from Siemens Healthcare. 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.
