Siemens Healthcare recalls Atellica Sample Handler software version 1.13 and lower due to potential incorrect test results. Affected users should check their software version and contact Siemens for updates.
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 Sample Handler software versions 1.13 and lower because they can cause incorrect test results. This affects laboratory equipment used for in vitro diagnostic testing.
The software issues can lead to incorrect test results by failing to read sample barcodes, misinterpreting dilution factors, or displaying wrong units. These problems may occur when multiple reagent lots are loaded or specific assay configurations are used.
Laboratories using Siemens Atellica Sample Handler systems with software version 1.13 or lower are affected. Users most at risk are those running specific tests like CEA dilutions or sample barcode reading.
Check if your Atellica Sample Handler has software version 1.13 or lower. The product is sold under the brand name Siemens Healthcare Diagnostics.
Verify your Atellica Sample Handler software version; if it is 1.13 or lower, it is affected.
The software version 1.13 and lower has five identified issues that can cause incorrect test results, including problems with sample barcodes, dilution calculations, and unit displays.
Check your software version; if it is 1.13 or lower, contact Siemens Healthcare for an update to a newer software version.
The recall addresses potential incorrect test results, which could affect diagnostic accuracy, but does not pose a direct safety risk like injury or fire.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0191-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0191-2019 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.
