CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Company
- Ventana Medical Systems Inc
- Recall Initiated
- August 2, 2018
- Posted
- September 14, 2018
- Terminated
- November 22, 2021
- Recall Number
- Z-3013-2018
- Quantity
- 240 units
- Firm Location
- Oro Valley, AZ
Reason for Recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Distribution
worldwide
Lot / Code Info
Lot Numbers: Y16507, Y23040, UDI: 4015630984398
Root Cause
Under Investigation by firm
Action Taken
The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
More recalls by Ventana Medical Systems Inc
VENTANA PD-L1 (SP142)
VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001
VENTANA PD-L1 (SP...
Jan 6, 2023
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Apr 8, 2022