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

Recalled October 9, 2024 · FDA recall Z-3304-2024 · Siemens Healthcare Diagnostics

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. · FDA Class II

Units

5622 kits

Sold at

Worldwide distribution - US Nationwide.

Description

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.

Product

ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →