VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody 05867061001Recalls & 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 04015630981083), received between Jun 12, 2025 and Jun 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
- Inaccurate Information1
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.
MalfunctionJun 12, 2025Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information
THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH A LABEL ON A VENTANA ANTI-P63 (4A4) MOUSE MONOCLONAL PRIMARY ANTIBODY REAGENT BOTTLE FOR USE ON A BENCHMARK ULTRA STAINER MODULE. AFTER OPENING THE REAGENT PACKAGE, THE BARCODE LABEL SHOWED P63, BUT THE REAGENT LABEL WAS FOR "ER". AFTER THE REAGENT BOTTLE WAS REGISTERED ON THE STAINER MODULE, THE INFORMATION WAS CONSISTENT WITH THE BARCODE (P63). THE CUSTOMER WAS UNSURE OF THE REAGENT COMPOSITION, SO THEY DID NOT USE THE REAGENT BOTTLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22194088 ↗
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- intelliPATH FLX™ DAB Chromogen Kit IPK5010G80Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
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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.
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