medical Class II Updated 2024-02-14

Siemens Healthcare Diagnostics, Inc. recalls Total immunoglobulin M (IgM total) IVD, kit, nephelometry/tu

Recalled Product

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry


Hazard / Issue

Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Siemens Material Number (SMN): 11097620; UDI DI: 00630414595627; Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), 232025 (11/01/2024).
View official government recall

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