Class II

Medical Device Recall: ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

Siemens Healthcare Diagnostics, Inc. · August 21, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

5622 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3304-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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