FDADecember 1, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

¿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

What to do

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414595566

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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