FDA-Device2018-09-26Class I

NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.

Ventana Medical Systems Inc
Hazard

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

Sold states
worldwide
Affected count
2172 units
Manufactured in
1910 E Innovation Park Dr, N/A, Oro Valley, AZ, United States
Products
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3015-2018

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