The Recall Desk

FDA (Devices) recall action 97961

Copan Italia recalled 2 products on 2025-12-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-12-24
Critical
0
Units
245,700

Why these products were recalled

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2025-12-24

    Sputum transfer reagent sets recalled because liquification cannot be guaranteed

    Copan Italia is recalling 122,850 units of 1ml DTT reagent supplied with a sputum transfer device because treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

    Product
    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
    Category
    Distribution
    14 states