FDA recall Z-3004-2018

Ventana Medical Systems Inc · Class I · device

Product

ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 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-3004-2018