Reported Feb 14, 2024 · Ongoing
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
- Lot codes and dates
- Siemens Material Number (SMN)11097620
- UDI DI00630414595627; Lot No. (Exp
- Date)
221764 (10/01/2023)221829 (02/01/2024)231915 (06/01/2024)232025 (11/01/2024)
- Amount recalled
- 7,075 units (927 US, 6148 OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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