FDA Enforcement
Class I
Terminated
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Recall: Z-3009-2018
·
Reported September 26, 2018
Enforcement
- Recall Number
- Z-3009-2018
- Event ID
- 80807
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ventana Medical Systems Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 26, 2018
- Initiation Date
- August 2, 2018
- Classification Date
- September 14, 2018
- Termination Date
- November 22, 2021
- Address
- 1910 E Innovation Park Dr, N/A, Oro Valley, AZ, 85755-1962, United States
Description
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Code Info
Lot Number: Y20881, UDI: 4015630984534
Distribution
worldwide
Quantity
75 units