Device product
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3000-2018
Product summary
- Event
- Event 80807
- Status
- Terminated
- Classification
- Class I
- Quantity
- 461 units
- Official record key
device-enforcement:Z-3000-2018
Official wording
Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Code information: Lot Number: Y26282, UDI: 4015630984749
Distribution pattern: worldwide
Derived failure modes
-
Unknown
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.