Siemens Healthcare IgM Test Kits May Give False Low Results
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.
Lower-risk recall
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/56557-siemens-healthcare-igm-test-kits-may-give-false-low-results.
Source Summary by GovInfoNow · govinfonow.com/recall/56557-siemens-healthcare-igm-test-kits-may-give-false-low-results · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1003-2024
Cite this page
“Siemens Healthcare IgM Test Kits May Give False Low Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56557-siemens-healthcare-igm-test-kits-may-give-false-low-results. Based on FDA recall #Z-1003-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1003-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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).
- Brand
Siemens Healthcare- Category
Medical device
What to do — step by step
Check Kit Lot Number
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).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 39 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and PR; The…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1003-2024 (December 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1003-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.