Siemens recalls Atellica Sample Handler Prime software versions 1.14.2 and lower due to potential incorrect test results. Affected units may need software update to prevent errors in clinical testing.
Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime
Siemens is recalling Atellica Sample Handler Prime devices with software versions 1.14.2 and older because these versions may cause incorrect test results. This could lead to inaccurate clinical diagnoses if the device is used without updating the software.
The software in versions 1.14.2 and lower may not handle certain test results correctly, potentially leading to inaccurate clinical test outcomes. This could affect the reliability of diagnostic results for patient care.
Healthcare facilities using Atellica Sample Handler Prime with software versions 1.14.2 or older are most at risk. Clinical labs that perform in vitro diagnostic testing on patient samples may be affected.
Check if your Atellica Sample Handler Prime has software version 1.14.2 or lower. The product uses Siemens Material Number (SMN) 11069001 for in vitro diagnostic testing of clinical specimens.
Contact Siemens Healthcare to update the software to version 1.14.3 or higher to fix the issue.
Software versions 1.14.2 and lower are affected.
Check the software version on your Atellica Sample Handler Prime device; versions 1.14.2 or lower are affected.
No, you can continue using the device as long as you update the software to version 1.14.3 or higher.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0783-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0783-2019 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.
