Medical device recalls Moderate risk

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

Recall date
October 29, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0943-2026
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 fluidification 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

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