ADVIA Chemistry Total Bilirubin_2 assay-
SMN: 10341115 (40 mL) & 10341113 (70 mL).
Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. 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).
Recall Date: Feb 13, 2020
Siemens Healthcare Diagnostics, Inc.
Recall ID: 85037
Product ID: 179952
Enforcement Date: Apr 1, 2020
Termination Date: Apr 23, 2021
Last Published: Apr 23, 2021
Emert Number: Z-1539-2020
Emert Status: Terminated