Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Total immunoglobulin M (IgM total) IVD Recalled by Siemens Healthcare Diagnostics, Inc. Due to Potential for a negative bias with quality control...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Quantity: 7,075 units (927 US, 6148 OUS)
Why Was This Recalled?
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report