Class II

Medical Device Recall: 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

Copan Italia · October 29, 2025

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

States Affected

CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT

Quantity Affected

122,850 units US

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0943-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.