Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide. Quantity: 5622 kits Lot/code info: UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337

UPC codes

00630414587837, 00630414587844

Source

Official record: FDA (Device enforcement) ↗

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