FDA-Device2018-09-26Class I
ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 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
2136 units
Manufactured in
1910 E Innovation Park Dr, N/A, Oro Valley, AZ, United States
Products
ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3002-2018Don't want to check this manually?
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