Siemens Healthcare Diagnostics product recalled over hepatitis A risk

Recall date

February 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Siemens Healthcare Diagnostics, Inc. recalls Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10…

Recall number

Z-1540-2020

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

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, Un…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.