Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for

Recalled April 1, 2020 · FDA recall Z-1538-2020 · Siemens Healthcare Diagnostics

Hazard

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

Units

1901 Us and 37349 OUS

Sold at

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Description

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

Product

ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

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