ultraView Universal DAB Detection Kit 250 testsRecalls & reported problems
Ventana Medical Systems, Inc. · Class 1
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- Aug 2, 2018Terminated
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-2997-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other IMMUNOHISTOCHEMISTRY REAGENTS AND KITS devices
- OptiView DAB Detection Kit 06396500001Ventana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS3 recalls0 reports
- OptiView Amplification Kit 06718663001Ventana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS2 recalls0 reports
- iVIEW DAB Detection Kit 250 testsVentana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS2 recalls0 reports
- FLEX Mono Mo A-Hu CD20cy Cl L26 RTU (Dako Omnis) GA604Agilent Technologies Singapore Pte Ltd · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS1 recall3 reports
- ULTRAVIEW UNIVERSAL AP RED DETECTION KIT 05269814001Ventana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS1 recall1 report
- intelliPATH™ Universal HRP Detection Kit IPK5011G80Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
- intelliPATH FLX™ DAB Chromogen Kit IPK5010G80Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
- intelliPATH Folate Receptor alpha IHC Assay Kit IPI4006KG10Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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