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PathVysion 02J05-030Recalls & reported problems

Abbott Molecular Inc. · ProbeChek PathVysion HER-2/neu Normal Control Slides · Class 2

Data updated Oct 13, 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 00884999001855), received between Dec 8, 2015 and Dec 8, 2015 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Damaged Prior to Use1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 8, 2015Device Damaged Prior to Use

    CUSTOMER REPORTED RECEIPT OF (1) BROKEN SLIDE IN (1) BOX OF PROBECHEK CONTROL SLIDES FOR THE PATHVYSION HER-2 DNA PROBE KIT. THERE WAS NO EVIDENCE OF EXTERNAL SHIPPING DAMAGE TO THE BOX. NO INJURY WAS REPORTED. BECAUSE THE PROBECHEK CONTROL SLIDES CONTAIN HUMAN SOURCED COMPONENTS, IF THE ISSUE OF BROKEN PROBECHEK SLIDES WERE TO RECUR, THERE IS POTENTIAL FOR EXPOSURE TO INFECTIOUS MATERIAL THAT MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY.

    Patient problems: No Patient Involvement

    MAUDE report 5275490 ↗

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Sources and updates

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