PathVysion 02J04-030Recalls & reported problems
Abbott Molecular Inc. · ProbeChek PathVysion HER-2/neu Cut-Off Control Slides · Class 2
Data updated Oct 16, 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 00884999001831), received between Nov 1, 2022 and Nov 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 16, 2026.
Most reported problems
Device problems
- Device Damaged Prior to Use1
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.
MalfunctionNov 1, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
THE CUSTOMER REPORTED THAT THEY RECEIVED A BROKEN SLIDE CONTAINED WITHIN PROBECHEK HER-2/NEU CONTROL SLIDES FOR FLUORESCENCE IN SITU HYBRIDIZATION (FISH) USING PATHVYSION HER-2 DNA PROBE KIT. THE CUSTOMER CONFIRMED NO ONE ON SITE WAS INJURED BY THE BROKEN SLIDES. CUSTOMER STATED THAT THEY DID NOT ATTEMPT TO USE THE BROKEN SLIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15711041 ↗
Other Dna-probe kit, human chromosome devices
- Vysis 06N38-010Abbott Molecular Inc. · Dna-probe kit, human chromosome2 reports
- UroVysion 02J27-011Abbott Molecular Inc. · Dna-probe kit, human chromosome2 reports
- Vysis 05J38-010Abbott Molecular Inc. · Dna-probe kit, human chromosome1 report
- Vysis 05J38-050Abbott Molecular Inc. · Dna-probe kit, human chromosome1 report
- Vysis 06N38-005Abbott Molecular Inc. · Dna-probe kit, human chromosome1 report
- PathVysion 02J05-030Abbott Molecular Inc. · Dna-probe kit, human chromosome1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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