Medical device recalls Moderate risk

Copan Italia recalls 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with…

Recall date
October 29, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0942-2026
FDA classification
Class II
Brand / firm
Copan Italia
Sold / distributed
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT

Why it was recalled

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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