Recall Z-0942-2026 ยท PPM General Purpose Reagent
Copan Italia
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
| Date | Dec 18, 2025 (initiated Oct 29, 2025) |
| Status | Open, Classified |
| Reason | Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. |
| Root cause | Under Investigation by firm |
| Action | On October 29, 2025, Copan initiated a Urgent: Medical Device Recall Notification via Email to affected consignees Copan ask consignees to take the following actions: 1. Further distribution or use of the remaining product must stop immediately: trace and dispose of all affected products. 2. This notice should be passed on to all those who need to be aware within your organization. 3. Ensure that the same obligations (communication to end users and related evaluation activities) are guaranteed by any additional Customer. In particular, if you have further distributed the devices, please pr |
| Quantity | 122,850 units US |
| Distribution | US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.