Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubi

Recalled April 1, 2020 · FDA recall Z-1541-2020 · Siemens Healthcare Diagnostics

Hazard

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

Units

N/A

Sold at

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Description

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

Product

Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

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