Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test
Recalled Product
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Hazard / Issue
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337
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