Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is

Recalled April 1, 2020 · FDA recall Z-1539-2020 · Siemens Healthcare Diagnostics

Hazard

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy · FDA Class II

Units

5666 US and 52202 OUS

Sold at

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Description

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

Product

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).

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →