FDA-Device2018-09-26Class I

VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc
Hazard

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers

Sold states
worldwide
Affected count
559 units
Manufactured in
1910 E Innovation Park Dr, N/A, Oro Valley, AZ, United States
Products
VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3008-2018

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