FDA recall Z-3000-2018

Ventana Medical Systems Inc · Class I · device

Product

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.

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-3000-2018