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FDAFebruary 13, 2020device

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 scre...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

0063041451308900630414513065

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 scre... — Recall Details · AllClear