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

Hazard

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

Details from the source

Reason for 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. 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 countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Curacao, Czech Republic, Denmark, Egypt, Estonia, Finland Quantity: 7,075 units (927 US, 6148 OUS) 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).

UPC codes

00630414595627

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.