Device product
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Z-0943-2026
Product summary
- Firm
- Copan Italia
- Event
- Event 97961
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 122,850 units US
- Official record key
device-enforcement:Z-0943-2026
Official wording
Reason: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Code information: UDI:0U020N.A - (01)18053326005043
Distribution pattern: US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Derived failure modes
-
Unknown
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.