Siemens Healthcare recalls Atellica Sample Handler Prime software version 1.13 and lower due to potential incorrect test results. Affected users should update software to fix issues with reagent locks, sample barcodes, and dilution calculations.
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 Prime software versions 1.13 and lower because they can cause incorrect test results. This affects lab equipment used for clinical testing, where errors might lead to wrong diagnoses.
The software issues can cause reagent locks to malfunction, sample barcodes to be misread, and dilution calculations to fail for specific tests like CEA. This may lead to incorrect test results if the equipment is used without proper software updates.
Lab technicians and healthcare facilities using the Atellica Sample Handler Prime system with software version 1.13 or lower are most at risk. The hazard is specific to certain testing scenarios but does not cause immediate harm.
Check if your Atellica Sample Handler Prime system has software version 1.13 or lower. The product is sold by Siemens Healthcare for in vitro diagnostic testing equipment.
Install the latest software version from Siemens Healthcare to fix the identified issues.
Siemens Healthcare identified five software issues that could cause incorrect test results, including problems with reagent locks, sample barcodes, and dilution calculations.
No, you can continue using the equipment as long as you update the software to the latest version to avoid the issues.
The issues affect CEA dilutions at 50x and 100x, reagent lock functionality with multiple lots of reagent kits, and certain assay results for the Atellica CH 930 Analyzer.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0189-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0189-2019 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.
