Device product
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Z-3305-2024
Product summary
- 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
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.