Siemens Healthcare Diagnostics, Inc.: Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (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: 9783 kits Lot/code info: UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336

UPC codes

00630414597935, 00630414597942

Source

Official record: FDA (Device enforcement) ↗

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