Siemens Healthcare recalls Atellica IM CA 19-9 tests that may show falsely high results near the upper limit of normal for certain 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 show falsely high results for some samples near the upper limit of normal. This could lead to incorrect medical decisions if the test is used without knowing the potential bias.
The test may show falsely high results for some samples near the upper limit of normal (35 U/mL) in certain populations. This bias is most noticeable in Asia Pacific samples and becomes less significant at higher concentrations (above 110 U/mL). The bias does not affect all test results uniformly across the measurement range.
People using Atellica IM CA 19-9 test kits with specific lot numbers for CA 19-9 tumor marker testing. Those in Asia Pacific populations may be at slightly higher risk due to the observed bias pattern.
Check the kit lot number on the test kit label. Affected kits have lot number 56434535 and were sold with Siemens Atellica CI or IM Analyzers. The product was distributed with specific serial numbers and dates.
Look for lot number 56434535 on the test kit label.
The test may show falsely high results for some samples near the upper limit of normal (35 U/mL), particularly in Asia Pacific populations. This could lead to incorrect medical decisions if the test is used without knowing the potential bias.
No, this is a potential for inaccurate test results, not a physical safety hazard. The risk is low and only affects specific test results in certain populations.
Check the kit lot number on the test kit label. Affected kits have lot number 56434535 and were sold with Siemens Atellica CI or 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-3102-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3102-2024 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.
