medical Class II Updated 2024-12-11

Siemens Healthcare Diagnostics, Inc. recalls Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic us

Recalled Product

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


Hazard / Issue

Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00630414595566 All in-date and future Atellica CH B2M reagent lots
View official government recall

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