Device product
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Z-3304-2024
Product summary
- 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
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.