Siemens Healthcare recalls Atellica IM CA 19-9 tests that may show false high results near the upper limit of normal for some samples, particularly in Asia Pacific populations. Affected kits have specific lot numbers and were sold with certain analyzers.
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
Siemens Healthcare is recalling Atellica IM CA 19-9 test kits that may give false high results for some samples near the upper limit of normal. This could lead to incorrect health decisions if used without knowing the test might be inaccurate.
The test may show falsely elevated CA 19-9 levels near the upper limit of normal (35 U/mL) for some samples, especially in Asia Pacific populations. This bias is less noticeable at higher concentrations (above 110 U/mL) and does not affect all test results.
People using Atellica IM CA 19-9 test kits for CA 19-9 tumor marker testing are affected. Those in Asia Pacific regions may be at slightly higher risk due to the specific sample bias observed.
Check for the lot number 55977535 on the test kit. The product was sold with Atellica CI or Atellica IM Analyzers and has the UDI-DI code (01)00630414598161(10)55977535(17)20240914.
Look for the lot number 55977535 on the test kit packaging.
The test may show false high results for some samples near the upper limit of normal, especially in Asia Pacific populations.
No, this is a potential for inaccurate results, not a safety hazard that could cause injury.
Check for the lot number 55977535 on the test kit, which was sold with Atellica CI or Atellica IM Analyzers.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3101-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3101-2024 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.
