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OptiView Amplification Kit 06396518001Recalls & reported problems

Ventana Medical Systems, Inc. · Class 1

All models of OptiView Amplification Kit (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Dec 19, 2017Class ITerminated

    Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.

    Z-0736-2018 · Root cause: Process control · Recall details · FDA record ↗

Other IMMUNOHISTOCHEMISTRY REAGENTS AND KITS devices

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Sources and updates

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