Vysis 04N02-021Recalls & reported problems
Abbott Molecular Inc. · Vysis CLL 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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884999042780), received between Aug 26, 2021 and Aug 26, 2021 — 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 16, 2026.
Recalls naming this device
- Aug 4, 2021Terminated
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
Z-2576-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
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 26, 2021False Negative Result; False Negative Result
CUSTOMER REPORTED CONCERN DUE TO HAVING TESTED PATIENT SAMPLES WITH CLL FISH PROBE KIT LOT, 518656 AND 517068. ON JULY 27TH, THE CUSTOMER EXPRESSED CONCERN TO THEIR AMBASSADOR AFTER READING A POST PUBLISHED BY (B)(6) UNIVERSITY. CUSTOMER LATER RECEIVED FA-AM-AUG2021-258A (TICKET (B)(4)), WHICH ACKNOWLEDGES THAT VYSIS CLL FISH PROBE KIT, LIST 04N02-021 LOTS 517086 AND 518656 HAVE BEEN LINKED TO REPORTS OF THE VYSIS CLL FISH PROBE KITS NOT DETECTING 13Q DELETIONS IN KNOWN POSITIVE PATIENT SAMPLES. NEW LOT OF CLL FISH PROBE WAS SHIPPED TO CUSTOMER AND PREVIOUSLY RELEASED NEGATIVE PATIENT SAMPLES ARE TO BE VERIFIED WITH THE NEW LOT. TICKET WAS MARKED AS POTENTIAL REPORTABLE EVENT (PRE) DUE TO POTENTIAL IMPACT ONCE PATIENT SAMPLES ARE RE-TESTED. AT THIS TIME NUMBER OF PATIENT SAMPLES POSSIBLY AFFECTED IS NOT KNOWN. IMPACT TO PATIENT MANAGEMENT IS NOT KNOWN. CUSTOMER FOLLOW UP INDICATES THAT PATIENT RE-TESTING HAS NOT TAKEN PLACE DUE TO SHORTAGE OF REAGENT SUPPLY. CUSTOMER WILL BE OUT OF OFFICE WEEK OF AUG 23RD. AT THIS TIME, THERE IS NO ALLEGATION OF DISCREPANT RESULTS, HOWEVER THIS EVALUATION WILL BE PROCESSED AS A WORST CASE FALSE NEGATIVE RESULT ON CLL PROBE, 4N02-21, WHICH IS ASSOCI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12375637 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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