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Recall Observatory FDA recall evidence

Device product

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

Z-3305-2024

August 21, 2024

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 95259
Status
Ongoing
Classification
Class II
Quantity
9783 kits
Official record key
device-enforcement:Z-3305-2024

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 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336

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.