Siemens Healthcare Diagnostics, Inc.: 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 di

Is my product affected?

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 measure

• UPC 00630414595801

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling the Atellica CH Direct Bilirubin_2 assay, an in vitro diagnostic test used to measure direct bilirubin levels in patient blood samples. The recall affects 577 units distributed in the United States and 2,617 units distributed internationally across numerous countries in Europe, Asia, Africa, and other regions. The affected lots are identified by UDI numbers 190273, 190187, and 190120.

The reason for the recall is that the bilirubin assays may exhibit a positive bias (higher readings than actual values) in patients taking eltrombopag, a medication used to treat low platelet counts. This inaccuracy could result in overestimation of bilirubin levels in affected patients. The recall notice does not specify a remedy or corrective action for consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Distribution: Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Azerbaijan, Baham Quantity: 577 US and OUS 2617 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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