Siemens Healthcare recalls ADVIA Centaur CA 19-9 tests due to potential positive bias in samples near upper limit of normal. This may affect results for CA 19-9 tumor marker testing.
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 ADVIA Centaur CA 19-9 tests that may show falsely high results for CA 19-9 near the upper limit of normal. This could lead to inaccurate tumor marker testing, especially in Asia Pacific populations.
The test may show falsely high results for CA 19-9 in some samples near the upper limit of normal (35 U/mL). This bias is most noticeable in Asia Pacific populations and less severe for samples above 110 U/mL.
Lab users testing CA 19-9 tumor markers with ADVIA Centaur systems are affected. Patients in Asia Pacific regions may be at slightly higher risk due to the specific population impact.
Check for the ADVIA Centaur CA 19-9 (250 Test) with lot numbers 55972535 or 55973535. The product uses Atellica CI or Atellica IM Analyzers for in vitro diagnostic testing.
Look for lot numbers 55972535 or 55973535 on the test kit packaging.
The recall addresses potential false high results in specific samples, not immediate patient risk. This may affect test accuracy but does not cause injury.
The bias is most pronounced in Asia Pacific populations based on the recall notice.
The test may show falsely high CA 19-9 levels near the upper limit of normal (35 U/mL), especially in Asia Pacific populations.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3104-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3104-2024 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.
