medical Class II Updated 2020-04-01

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for

Recalled Product

Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # UDI Number 190273 (01)00630414595801(10)190273(17)20201203 190187 (01)00630414595801(10)190187(17)200820 190120 (01)00630414595801(10)190120(17)200521
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