Device product
ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-2997-2018
Product summary
- Event
- Event 80807
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,655 units
- Official record key
device-enforcement:Z-2997-2018
Official wording
Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Code information: Lot Numbers: Y25695, Y22147, UDI: 4015630972173
Distribution pattern: worldwide
Derived failure modes
-
Unknown
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.