iVIEW DAB Detection Kit 250 testsRecalls & reported problems
Ventana Medical Systems, Inc. · Class 1
All models of iVIEW DAB Detection Kit (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records 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-2998-2018 · 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-0731-2018 · Root cause: Process control · 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
- 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
- VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody 05857856001Ventana Medical Systems, Inc. · 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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