Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-3304-2024

August 21, 2024

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 95259
Status
Ongoing
Classification
Class II
Quantity
5622 kits
Official record key
device-enforcement:Z-3304-2024

Official wording

Reason: 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.

Code information: UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337

Distribution pattern: Worldwide distribution - US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.