Recall Z-3000-2018— Ventana Medical Systems Inc

Name: FDA recall Z-3000-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-02

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: OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 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

OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 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.