Siemens Healthcare recalls ADVIA Centaur CA 19-9 test kits that may show higher results near the upper limit of normal, affecting some Asian Pacific samples. Consumers should check kit lot numbers and contact Siemens for details.
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 test kits that may show higher results than actual for some samples near the upper limit of normal. This could lead to inaccurate cancer marker measurements, especially in Asian Pacific populations.
The test kits may show higher results than actual for samples near the upper limit of normal (35 U/m). This bias is most noticeable in Asian Pacific populations and less severe for samples with higher cancer marker levels (above 110 U/mL).
People using ADVIA Centaur CA 19-9 test kits for cancer marker testing. Those in Asian Pacific populations may be at slightly higher risk of inaccurate results.
Check the kit lot numbers: 55970535 or 55971535. These kits were sold with specific serial numbers and dates.
Look for lot numbers 55970535 or 55971535 on the test kit packaging.
No, the recall does not require stopping use. The kits may have measurement bias but are still safe to use.
Results near the upper limit of normal (35 U/m) may be higher than actual, especially in Asian Pacific populations.
Check the kit lot numbers. If they match 55970535 or 55971535, contact Siemens Healthcare for further instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3103-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3103-2024 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.
