Siemens Healthcare Diagnostics, Inc.: Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vi

Is my product affected?

Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates

• UPC 00630414595818

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

What happened

Siemens Healthcare Diagnostics is recalling the Atellica CH Total Bilirubin_2 assay, an in vitro diagnostic test used to measure total bilirubin levels in blood. The recall affects 2,323 units distributed in the United States and 8,193 units distributed internationally across numerous countries. The recall involves seven specific lots with expiration dates ranging from April 2020 through March 2021.

The reason for the recall is that bilirubin assays may show a positive bias (falsely elevated results) in patients taking eltrombopag therapy. The source document does not specify a remedy or corrective action for consumers.

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: 2323 US and 8193 OUS Lot/code info: Lot # UDI Number 190028 (01)00630414595818(10)190028(17)20200420 190063 (01)00630414595818(10)190063(17)20200601 190112 (01)00630414595818(10)190112(17)20200810 190152 (01)00630414595818(10)190152(17)20201005 190205 (01)00630414595818(10)190205(17)20201221 190235 (01)00630414595818(10)190235(17)20210118 190265 (01)00630414595818(10)190265(17)20210301

Source

Official record: FDA (Device enforcement) ↗

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

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