Copan Italia: Device Recall
Recall #Z-0942-2026 · 10/29/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0942-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Copan Italia
- Status
- Ongoing
- Date Initiated
- 10/29/2025
- Location
- Brescia, Italy
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 122,850 units US
Reason for Recall
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Product Description
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
Distribution Pattern
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Other Recalls by Copan Italia
- Class II: Risk 10/29/2025
- Class II: Risk 05/02/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.