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
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