Vysis 06N38-005Recalls & reported problems
Abbott Molecular Inc. · ProbeChek ALK Negative Control Slides · Class 2
- 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 00884999025721), received between Aug 21, 2024 and Aug 21, 2024 — 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.
Reports received per month
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.
MalfunctionAug 21, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
THE CUSTOMER REPORTED RECEIPT OF A BROKEN SLIDE OF PROBECHEK ALK NEGATIVE CONTROL SLIDES II. THERE WAS NO INJURY OR IMPACT AS A RESULT OF THE BROKEN SLIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20020979 ↗
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
- PathVysion 02J05-030Abbott Molecular Inc. · Dna-probe kit, human chromosome1 report
- PathVysion 02J04-030Abbott Molecular Inc. · Dna-probe kit, human chromosome1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.