Siemens recalls Atellica IM1300 analyzers with specific sample cups due to risk of missing low sample volumes. Affected units may need replacement to prevent inaccurate test results.
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 IM1600 analyzers.
Siemens is recalling Atellica IM1300 analyzers with certain sample cups because they might not detect small sample volumes properly. This could lead to inaccurate test results if the analyzer is used without the correct sample volume.
The analyzer may fail to detect low sample volumes when using specific sample cups, leading to inaccurate test results. This happens because the cups' design doesn't properly measure small sample amounts.
Healthcare labs using Siemens Atellica IM1300 analyzers with Tube Top Sample Cups (1mL or 2mL) are most at risk. Patients relying on these analyzers for blood tests may experience inaccurate results.
Check for Siemens Material Number 11066001 on the analyzer and Tube Top Sample Cups with SMN 11069061 (1mL) or 11069062 (2mL). The recall includes specific Sarstedt sample cups as well.
Verify if your sample cups have Siemens Material Numbers 11069061 or 11069062 for 1mL or 2mL sizes.
Use only sample cups with the correct Siemens Material Numbers to ensure accurate test results.
The Atellica IM1300 analyzer may not detect low sample volumes when using specific Tube Top Sample Cups, leading to inaccurate test results.
Tube Top Sample Cups with Siemens Material Numbers 11069061 (1mL) or 11069062 (2mL).
No, but you should use only the correct sample cups to avoid inaccurate test results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2404-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2404-2020 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.