Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Reason: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Code information: Lot # UDI Number 190028 (01)00630414595818(10)190028(17)20200420 190063 (01)00630414595818(10)190063(17)20200601 190112 (01)00630414595818(10)190112(17)20200810 190152 (01)00630414595818(10)190152(17)20201005 190205 (01)00630414595818(10)190205(17)20201221 190235 (01)00630414595818(10)190235(17)20210118 190265 (01)00630414595818(10)190265(17)20210301

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