Siemens Healthcare Diagnostics, Inc. recalls Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN:

Recalled April 1, 2020 · FDA recall Z-1540-2020 · Siemens Healthcare Diagnostics

Hazard

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

Units

1639 US and 747 OUS

Sold at

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Description

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

Product

Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension 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 →