anti-c-MYC (Y69) Rabbit Monoclonal Primary Antibody 06504612001Recalls & reported problems
Ventana Medical Systems, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630984046), received between Sep 23, 2026 and Sep 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Chemical Reaction” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Improper Chemical Reaction1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Improper Chemical Reaction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873363 ↗
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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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