Vysis 06J96-001Recalls & reported problems

Abbott Molecular Inc. · CGH Target Slides Normal Metaphase · 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 00884999023512), received between Mar 26, 2025 and Mar 26, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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

Device Damaged Prior to Receipt by User1

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 26, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
THE CUSTOMER REPORTED RECEIVING ONE BROKEN SLIDE IN THEIR ORDER OF CGH TARGET SLIDES NORMAL METAPHASE SLIDES. THE CUSTOMER WAS WEARING LATEX GLOVES AND NO ONE WAS INJURED. THE SLIDES WERE REPLACED WITH A NEW LOT. THERE WAS NO PATIENT INVOLVED AS THE BROKEN SLIDE WAS IDENTIFIED BY THE USER PRIOR TO USAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701044 ↗

Device details

UDI-DI	`00884999023512`
Brand	Vysis
Model	06J96-001
Company	Abbott Molecular Inc.
Product code	MVU · REAGENTS,SPECIFIC,ANALYTE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 5, 2018

Device type (GMDN): Nucleic acid hybridization detection IVD, probe

A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

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All REAGENTS,SPECIFIC,ANALYTE 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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