Class II

Medical Device Recall: Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (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

9783 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3305-2024

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.