Z-3305-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2024
- Initiation Date
- August 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9783 kits
Product Description
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336