Vysis 05J82-001Recalls & reported problems
Abbott Molecular Inc. · Vysis LSI BCR/ABL Dual Color Dual Fusion Probes · Class 1
All models of Vysis (9)
Data updated Oct 18, 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 00884999012592), received between Mar 27, 2025 and Mar 27, 2025 — 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 18, 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.
MalfunctionMar 27, 2025False Negative Result; False Negative Result
THE CUSTOMER REPORTED THAT THERE WAS A DISCREPANT PATIENT RESULT REPORTED AFTER TESTING WITH THE VYSIS LSI BCR/ABL, DUAL COLOR, DUAL FUSION TRANSLOCATION PROBE SET, LIST NUMBER (LN) 05J82-01, LOT 399485. SID (B)(6) RESULT WAS INTERPRETED AS A DELETION AND NOT A FUSION; 1R2G1F INSTEAD OF 1R1G2F ON (B)(6)2024. THIS WAS A DIAGNOSTIC SPECIMEN AND THE CUSTOMER IDENTIFIED THE ABNORMALITY WHEN THEY RECEIVED A BONE MARROW FOR THIS PATIENT THAT WAS CONFIRMED POSITIVE FOR BCR: ABL1 FUSION ON (B)(6)2025. THE CUSTOMER THEN WENT BACK AND REHYBRIDIZED WITH A NEW LOT AND IDENTIFIED THE FUSION (1R1G1F VARIANT PATTERN). THE REPORT WAS REVISED ON (B)(6)2025. THE CML TREATMENT FOR THE PATIENT WAS DELAYED FROM (B)(6)2024 TO (B)(6) 2025. THE VYSIS LSI BCR/ABL DUAL COLOR DUAL FUSION PROBES (LIST 05J82-001) IS AN ANALYTE SPECIFIC REAGENT (ASR). ANALYTICAL AND PERFORMANCE CHARACTERISTICS ARE NOT ESTABLISHED. THE CUSTOMER USED THE VYSIS LSI BCR/ABL DUAL COLOR DUAL FUSION PROBES (LIST 05J82-001) ASR IN THEIR LABORATORY DEVELOPED TEST (LDT). THE LDT TEST WAS DEVELOPED, AND ITS ANALYTICAL PERFORMANCE CHARACTERISTICS WERE DETERMINED BY THE CUSTOMER. IT HAS NOT BEEN CLEARED OR APPROVED BY THE US FOOD AND DRUG A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21709732 ↗
Other REAGENTS,SPECIFIC,ANALYTE devices
- N/A 340757Becton, Dickinson And Company · Reagents, specific, analyte1 recall1 report
- CytoCell LPS508-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
- Kreatech FISH probes 40V016V495Leica Biosystems Newcastle Ltd · Reagents, specific, analyte1 recall0 reports
- N/A 346587Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- CytoCell LPS509-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
- N/A 341098Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- N/A 340936Becton, Dickinson And Company · Reagents, specific, analyte1 recall0 reports
- N/A 340922Becton, Dickinson And Company · Reagents, specific, analyte1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page