Vysis 06N38-033Recalls & reported problems
Abbott Molecular Inc. · Vysis ALK Break Apart FISH Probe Kit · Class 2
All models of Vysis (9)
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 00884999042728), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
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 27, 2024False Negative Result; False Negative Result
THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON THE VYSIS ALK BREAK APART FISH. THE CUSTOMER TESTED A SAMPLE AND FOUND THAT IMMUNOHISTOCHEMISTRY (IHC) RESULTS AND PCR RESULTS WERE 90% POSITIVE, BUT THE FISH RESULTS WERE LESS THAN 5%. THE VYSIS ALK BREAK APART FISH'S MANUFACTURE DATE WAS MAY 2023 AND EXPIRATION DATE WAS APRIL 2024. THE KIT WAS EXPIRED AT THE TIME OF THE REPORTED EVENT. THE CUSTOMER REPORTED THAT THEY CAN SEE ALL FUSION SIGNAL AND DID NOT BELIEVE THE EXPIRED KIT WOULD CAUSE DIFFERENT RESULTS BETWEEN THE IHC AND PCR. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THE NEGATIVE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20076816 ↗
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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