1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Recall
- Recall Number
- Z-0943-2026
- Event Number
- 97961
- Firm
- Copan Italia Via Francesco Perotti 10
- FEI Number
- 3002444944
- Product Code
- PPM
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 29, 2025
- Posted
- December 18, 2025
- Address
- 18 Brescia Italy
Description
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
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 provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter, in writing. If you have any questions, call Chief Operating Officer, at 030-2687211.
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
122,850 units US