Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
FDA Recall #Z-3305-2024 — Class II — August 21, 2024
Product Description
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9783 kits
Distribution
Worldwide distribution - US Nationwide.
Code Information
UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated