VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody 05857856001Recalls & reported problems
Ventana Medical Systems, Inc. · 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
- Jun 27, 2024Class IIOpen, Classified
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
Z-2644-2024 · Root cause: Unknown/Undetermined 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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page