Siemens recalls Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostics. When multiple analyzers connect to one system, reporting errors may occur. No remedy specified in official notice.
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Siemens is recalling two in vitro diagnostic testing devices that could cause incorrect lab results if used with multiple analyzers. This affects clinical testing accuracy but does not pose immediate safety risks to users.
The system may produce incorrect reporting and conversion factors when more than one immunoassay analyzer is connected to a single solution system. This leads to potential lab result errors but does not involve physical harm or injury.
Healthcare labs using Atellica Solution and Atellica Sample Handler Prime for clinical testing are most affected. Patients and staff may receive inaccurate test results if multiple analyzers connect to a single system.
Check for the Atellica Solution or Atellica Sample Handler Prime devices used in clinical labs. The unique device identifier (UDI) 00630414002439 is associated with this recall.
Identify if your device is Atellica Solution or Atellica Sample Handler Prime used for clinical testing.
No. The recall addresses potential lab result errors, not physical harm or injury.
Check for the Atellica Solution or Atellica Sample Handler Prime devices with UDI 00630414002439.
The official notice does not specify a remedy, so contact Siemens Healthcare for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1587-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1587-2018 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.
