Vysis 05J70-001Recalls & reported problems

Abbott Molecular Inc. · Vysis LSI PML/RARA Dual Color Single 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 00884999012325), received between Jun 21, 2019 and Jun 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

Most reported problems

Device problems

Device Damaged Prior to Use1

Patient problems

No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 21, 2019Device Damaged Prior to Use; Device Damaged Prior to Use
THE CUSTOMER REPORTED THAT THE ABBOTT MOLECULAR FISH VYSIS PROBE VIAL ARRIVED CRUSHED INSIDE THE SHIPPING BOX, AND THE PRODUCT WAS NOT USABLE. THE OUTER SHIPPING BOX WAS INTACT, AND NO OUTSIDE BOX DAMAGE WAS OBSERVED. THE PROBE PACKAGING WAS INTACT, AND THERE WAS A LARGE PIECE OF ICE ON TOP OF THE PACKAGE. THE BROKEN VIAL WAS INSIDE THE PACKAGE. THE CUSTOMER USED PPE (PERSONAL PROTECTIVE EQUIPMENT) WHEN OPENING THE SHIPMENT. THERE WAS NO INJURY CAUSED BY THE BROKEN PLASTIC PROBE VIAL.
Patient problems: No Patient Involvement
MAUDE report 8724041 ↗

Device details

UDI-DI	`00884999012325`
Brand	Vysis
Model	05J70-001
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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