Siemens Healthcare recalls Atellica IM CA 19-9 tests that may show falsely high results near the upper limit of normal for some Asian Pacific samples. This could affect cancer screening accuracy.
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 falsely high results for some samples near the upper limit of normal, particularly in Asian Pacific populations. This could lead to inaccurate cancer screening results if the test is used without the recall fix.
The test may show falsely high CA 19-9 levels for some samples near the upper limit of normal (35 U/mL), especially in Asian Pacific populations. This bias is less noticeable for samples with higher levels (above 110 U/mL). The issue does not cause immediate harm but could lead to inaccurate cancer screening results.
People using Atellica IM CA 19-9 test kits for cancer screening in the Asia Pacific region. Those with recent test results near the upper limit of normal (35 U/mL) may be most affected.
Check for the kit lot number 55974535 or 55975535 on the Atellica IM CA 19-9 test kit. The product was sold with the serial number starting with SMN: 10995490.
Look for the kit lot number 55974535 or 55975535 on the test kit packaging.
No, this recall is for potential false high results in some samples, not a safety hazard. The test remains safe to use but may give inaccurate results.
The test may show falsely high CA 19-9 levels near the upper limit of normal (35 U/mL) for some Asian Pacific samples, which could lead to inaccurate cancer screening results.
No, you can continue using the test but should check the kit lot number and contact Siemens Healthcare if you have the affected lot numbers.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3100-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3100-2024 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.
