ISH iVIEW BLUE PLUS DETECTION KIT 05266181001Recalls & reported problems
Ventana Medical Systems, Inc. · Class 1
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
- Aug 2, 2018Class ITerminated
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Z-3002-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other General purpose reagent devices
- NeuMoDxTM Cartridge 100100Neumodx Molecular, Inc. · General purpose reagent3 recalls5 reports
- ultraView SISH DNP Detection Kit 100 testsVentana Medical Systems, Inc. · General purpose reagent2 recalls0 reports
- VITROS 6801754Ortho-Clinical Diagnostics, Inc. · General purpose reagent2 recalls0 reports
- VITROS 8430373Ortho Clinical Diagnostics · General purpose reagent1 recall0 reports
- IMMY TBPN67Immuno-Mycologics, Inc. · General Purpose Reagent1 recall0 reports
- STA® - Owren-Koller 00360Diagnostica Stago · General purpose reagent1 recall0 reports
- Ventana ISH iVIEW Blue Detection Kit 05278511001Ventana Medical Systems, Inc. · General purpose reagent1 recall0 reports
- ONCORE Pro DAB Chromogen OPRI6056KT180Biocare Medical LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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