Recall Z-3009-2018— Ventana Medical Systems Inc
Class I · Terminated
Class I FDA medical device recall by Ventana Medical Systems Inc, initiated 2018-08-02, terminated 2021-11-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Ventana Medical Systems Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-08-02
- Terminated
- 2021-11-22
- Firm location
- Oro Valley, AZ, United States
Product description
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Data sourced from openFDA. This site is unofficial and independent of the FDA.