medical Class II Updated 2024-10-09

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM aTPO Assay, Material Number 10995466 (100 Test)

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336
View official government recall

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