ultraView SISH DNP Detection Kit 100 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
- 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-2999-2018 · 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-0733-2018 · Root cause: Process control · Recall details · FDA record ↗
Other General purpose reagent devices
- NeuMoDxTM Cartridge 100100Neumodx Molecular, Inc. · General purpose reagent3 recalls5 reports
- VITROS 6801754Ortho-Clinical Diagnostics, Inc. · General purpose reagent2 recalls0 reports
- Ventana ISH iVIEW Blue Detection Kit 05278511001Ventana Medical Systems, Inc. · General purpose reagent1 recall0 reports
- ISH iVIEW BLUE PLUS DETECTION KIT 05266181001Ventana Medical Systems, Inc. · General purpose reagent1 recall0 reports
- ONCORE Pro DAB Chromogen OPRI6056KT180Biocare Medical LLC · General Purpose Reagent1 recall0 reports
- VITROS 8430373Ortho Clinical Diagnostics · General purpose reagent1 recall0 reports
- STA® - Owren-Koller 00360Diagnostica Stago · General purpose reagent1 recall0 reports
- IMMY TBPN67Immuno-Mycologics, Inc. · General Purpose Reagent1 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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