FDA recall Z-0943-2026

Copan Italia · Class II · device

Product

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

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-0943-2026