Vysis 05J38-050Recalls & reported problems

Abbott Molecular Inc. · AneuVysion DNA Probe Kit · Class 2

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 00884999011717), received between Dec 22, 2023 and Dec 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

False Positive 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.

MalfunctionDec 22, 2023False Positive Result; False Positive Result
THE CUSTOMER REPORTED A SAMPLE WITH AN ABNORMAL SIGNAL WHEN USING ANEUVYSION DNA PROBE KIT. THE CUSTOMER REPORTED ON (B)(6) 2023 THAT THE CEP-Y SIGNAL IS SMALL AND HAS REGULAR DOTS. ON (B)(6) 2023, THE CUSTOMER PERFORMED KARYOTYPE ANALYSIS AND A DNA MICROARRAY WHICH GAVE A RESULT OF Y-CHROMOSOME NORMAL. THE ABNORMAL Y CHROMOSOME RESULT WAS COMMUNICATED TO THE PATIENT. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18383280 ↗

Device details

UDI-DI	`00884999011717`
Brand	Vysis
Model	05J38-050
Company	Abbott Molecular Inc.
Product code	OYU · Dna-probe kit, human chromosome
Class	Class 2
FDA submission	K010288
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Multiple congenital aneuploidy screening IVD, probe

A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple congenital aneuploidies, including (but not limited to) trisomy 13 (Pätau syndrome), trisomy 18 (Edwards syndrome), trisomy 21 (Down syndrome), and sex chromosome aneuploidies.

Other Dna-probe kit, human chromosome devices

UroVysion 02J27-011
Abbott Molecular Inc. · Dna-probe kit, human chromosome
2 reports
Vysis 06N38-010
Abbott Molecular Inc. · Dna-probe kit, human chromosome
2 reports
PathVysion 02J05-030
Abbott Molecular Inc. · Dna-probe kit, human chromosome
1 report
PathVysion 02J04-030
Abbott Molecular Inc. · Dna-probe kit, human chromosome
1 report
Vysis 05J38-010
Abbott Molecular Inc. · Dna-probe kit, human chromosome
1 report
Vysis 06N38-005
Abbott Molecular Inc. · Dna-probe kit, human chromosome
1 report

All Dna-probe kit, human chromosome devices →

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.

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