Siemens Healthcare recalls IgM total test kits that may cause false low results in quality control and patient samples. Affected kits have specific lot numbers and expiration dates.
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Siemens Healthcare is recalling IgM total test kits that may give false low results in quality control and patient samples. This could lead to incorrect diagnoses if the test is used without noticing the issue.
The test kits may produce false low results when used with certain reagents, potentially leading to incorrect patient diagnoses. This happens due to a negative bias in the quality control process.
Healthcare labs using Siemens IgM test kits with specific lot numbers are affected. Patients receiving results from these kits may be at risk of incorrect diagnoses.
Check the lot number on the kit packaging. Affected kits have lot numbers 221764 (exp. 10/01/2023), 221829 (exp. 02/01/2024), 231915 (exp. 06/01/2024), or 232025 (exp. 11/01/2024).
Look for the lot number on the kit packaging to determine if it is affected. Affected lots are 221764 (exp. 10/01/2023), 221829 (exp. 02/01/2024), 231915 (exp. 06/01/2024), or 232025 (exp. 11/01/2024).
The test kits may produce false low results in quality control and patient samples, potentially leading to incorrect diagnoses.
Affected lot numbers are 221764 (exp. 10/01/2023), 221829 (exp. 02/01/2024), 231915 (exp. 06/01/2024), and 232025 (exp. 11/01/2024).
No, but you should check the lot number to ensure you are not using an affected kit.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1003-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1003-2024 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.
