FDA recall Z-3008-2018
Ventana Medical Systems Inc · Class I · device
Product
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers
Distribution
worldwide
Key facts
- Status
- Terminated
- Initiation date
- 2018-08-02
- Report date
- 2018-09-26
- Termination date
- 2021-11-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Oro Valley, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3008-2018