OptiView Amplification KitRecalls & reported problems across all models
Ventana Medical Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 2 models of OptiView Amplification Kit by Ventana Medical Systems, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
OptiView Amplification Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 2, 2018Terminated
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3000-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 19, 2017Terminated
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-0737-2018 · Root cause: Process control · Recall details · FDA record ↗
- Dec 19, 2017Terminated
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 ↗
OptiView Amplification Kit models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OptiView Amplification Kit 06718663001IMMUNOHISTOCHEMISTRY REAGENTS AND KITS2 recalls0 reports
- OptiView Amplification Kit 06396518001IMMUNOHISTOCHEMISTRY REAGENTS AND KITS1 recall0 reports
Other Ventana Medical Systems, Inc. products
All Ventana Medical Systems, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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