Drug recall
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
FDA recall event 97961 · Class II · Copan Italia
Key facts
| Event ID | 97961 |
|---|---|
| Recall numbers | Z-0942-2026, Z-0943-2026 |
| Recalling firm | Copan Italia |
| Product type | Devices |
| Products | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk, 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed., Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. |
| Initiation date | Oct 29, 2025 |
| Report date | Dec 24, 2025 |
| City | Brescia |
| Country | Italy |
| FEI number | 3002444944 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: