Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531 — recall Z-2471-2023
U.S. FDA — Device Enforcement · United States · 2023-07-10 · Class II
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Reported risk: Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿CH HDL Cholesterol (HDLC)
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