FDA recall Z-0942-2026

Copan Italia · Class II · device

Product

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

US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT

Key facts

Status
Ongoing
Initiation date
2025-10-29
Report date
2025-12-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brescia, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2026