ULTRAVIEW UNIVERSAL AP RED DETECTION KIT 05269814001Recalls & 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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630972258), received between Mar 23, 2026 and Mar 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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.
Reports received per month
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-3004-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- False Negative Result1
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionMar 23, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
THERE WAS AN ALLEGATION OF QUESTIONABLE STAINING RESULTS WITH THE ULTRAVIEW UNIVERSAL ALKALINE PHOSPHATASE RED DETECTION KIT USING THE BENCHMARK ULTRA INSTRUMENT. THE INITIAL TESTING OF A PATIENT BLOCK SHOWED FALSE-NEGATIVE RESULTS FOR SEVERAL MARKERS, ALTHOUGH THE CONTROLS WERE POSITIVE. A REPEAT STAINING WITH A DIFFERENT LOT OF THE SAME DETECTION KIT YIELDED THE EXPECTED POSITIVE RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664414 ↗
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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 · 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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