Z-3305-2024 Class II Ongoing
FDA device recall Z-3305-2024 was initiated by Siemens Healthcare Diagnostics, Inc. on Aug 21, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 9783 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2024
- Initiation Date
- Aug 21, 2024
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3305-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026