intelliPATH™ Universal HRP Detection Kit IPK5011G80Recalls & reported problems
Biocare Medical LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Sep 25, 2024Class IIOpen, Classified
Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
Z-0315-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Immunohistochemistry Reagents And Kits devices
- OptiView DAB Detection Kit 06396500001Ventana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS3 recalls0 reports
- iVIEW DAB Detection Kit 250 testsVentana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS2 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
- Ventana Basal Cell Cocktail 34BE12+p63 06419445001Ventana Medical Systems, Inc. · IMMUNOHISTOCHEMISTRY REAGENTS AND KITS1 recall0 reports
- intelliPATH FLX™ DAB Chromogen Kit IPK5010G80Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
- Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody 05266840001Ventana 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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