Medical device recalls High risk

Ventana Medical Systems Inc recalls iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

Recall date
August 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3001-2018
FDA classification
Class I
Brand / firm
Ventana Medical Systems Inc
Sold / distributed
worldwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

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