Z-0942-2026 Class II Ongoing

Recalled by Copan Italia — Brescia

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 + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System

Reason for Recall

Treatment reagent functionality in respiratory specimens liquification 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)18053326005036