Siemens Healthcare recalls Atellica Sample Handler Connect software version 1.13 and lower due to potential incorrect test results. Affected users should 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 Connect software versions 1.13 and lower. These versions can cause incorrect test results, sample misreads, or analyzer errors in specific diagnostic tests.
The software issues can cause sample barcodes to be read incorrectly, analyzers to fail with certain dilutions, and reporting units to remain unchanged after adjustments. These problems may lead to inaccurate test results in specific diagnostic scenarios.
Users of the Atellica Sample Handler Connect system with software version 1.13 or lower are affected. Laboratory technicians and medical professionals using this system for in vitro diagnostics are most at risk.
Check if your Atellica Sample Handler Connect system has software version 1.13 or lower. The product is used for in vitro diagnostic testing of clinical specimens.
Verify your Atellica Sample Handler Connect software version. Versions 1.13 and lower are affected.
Software versions 1.13 and lower are affected.
The affected software may cause incorrect sample barcode readings, analyzer errors with specific dilutions, and reporting units not updating after changes.
No, the recall does not require immediate discontinuation. Users should check their software version and contact Siemens for updates.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0190-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0190-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
