Device product
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
Z-3013-2018
Product summary
- Event
- Event 80807
- Status
- Terminated
- Classification
- Class I
- Quantity
- 240 units
- Official record key
device-enforcement:Z-3013-2018
Official wording
Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Code information: Lot Numbers: Y16507, Y23040, UDI: 4015630984398
Distribution pattern: worldwide
Derived failure modes
-
Unknown
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.