Class IIReported 2025-12-24

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

Recalled by Copan Italia

Reason for Recall

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

Recall Number

Z-0943-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-10-29

Reported

2025-12-24

Distribution

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

Code Info

UDI:0U020N.A - (01)18053326005043

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.