Z-0943-2026 Class II Ongoing
FDA device recall Z-0943-2026 was initiated by Copan Italia on October 29, 2025 and is designated Class II. Reason for recall: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. The recall status is ongoing. Affected quantity: 122,850 units US.
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2025
- Initiation Date
- October 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122,850 units US
Product Description
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Reason for Recall
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Distribution Pattern
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Code Information
UDI:0U020N.A - (01)18053326005043