Siemens recalls Atellica IM1600 analyzers with specific tube cups due to risk of missing sample detection. Affected units include Siemens Material Number 11066000 and certain tube cups. Consumers should check their model numbers and contact Siemens for details.
Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.
Siemens is recalling Atellica IM1600 analyzers and specific sample cups because they might not detect insufficient samples properly. This could lead to inaccurate test results if the analyzer doesn't catch low sample levels.
The analyzer may fail to detect when sample volume is too low, especially with certain sample cups. This could cause inaccurate test results if the sample isn't properly measured.
Users of Atellica IM1600 analyzers with Tube Top Sample Cups (1mL or 2mL) or Sarstedt 62.612 cups are affected. Laboratory technicians and medical professionals using these analyzers are most at risk.
Check for Siemens Material Number 11066000 on the analyzer and specific tube cup model numbers (11069061 for 1mL, 11069062 for 2mL) or Sarstedt 62.612 cups. The recall includes units sold with these components.
Look for Siemens Material Number 11066000 on the analyzer and tube cup model numbers (11069061 or 11069062) or Sarstedt 62.612 cups.
Tube Top Sample Cups (1 mL, SMN 11069061) and (2 mL, SMN 11069062), as well as Sarstedt 62.612 cups.
Check for Siemens Material Number 11066000 on the analyzer. Affected units were sold with the specific tube cups listed in the recall.
The recall does not specify a remedy, so contact Siemens Healthcare directly 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-2405-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2405-2020 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.
