Device product
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
Z-3001-2018
Product summary
- Event
- Event 80807
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10 units
- Official record key
device-enforcement:Z-3001-2018
Official wording
Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Code information: Lot Number: Y19981, UDI: 4015630970261
Distribution pattern: worldwide
Derived failure modes
-
Unknown
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.