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[Recalled] VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use. — Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispen… | FDA

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductVENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
Brand / manufacturerVentana Medical Systems Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-3008-2018
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date02 August 2018
EAN / barcode4015630971930

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Ventana Medical Systems Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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