medical Class II Updated 2022-01-05

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro di

Recalled Product

Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635


Hazard / Issue

¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 211446 UDI: 00630414595566
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →