1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
- Recall Initiated
- October 29, 2025
- Posted
- December 18, 2025
- Recall Number
- Z-0943-2026
- Quantity
- 122,850 units US
Reason for Recall
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Distribution
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Lot / Code Info
UDI:0U020N.A - (01)18053326005043
Root Cause
Under Investigation by firm
Action Taken
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.