FDAOctober 21, 2024device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
UPCs
00630414595566
Recall history
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