MMWClass II

System, Test, Tumor Marker, Monitoring, Bladder

Immunology · 21 CFR 866.6010

MDR events6All time

Recalls1All time

Registered firms5Currently listed

510(k) clearances9All time

Recent MDR events

6 adverse event reports on file

PROBECHEK MULTIVYSION CONTROL SLIDESNov 12, 2013
MalfunctionAbbott Molecular, Inc.3005248192-2013-00014
PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDESFeb 9, 2012
MalfunctionAbbott Molecular, Inc.3005248192-2012-00008
PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDESFeb 9, 2012
MalfunctionAbbott Molecular, Inc.3005248192-2012-00009
PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDESJan 16, 2012
MalfunctionAbbott Molecular, Inc.3005248192-2012-00004
PROBECHEK UROVYSION CONTROL SLIDESMay 20, 2011
MalfunctionAbbott Molecular, Inc.3005248192-2011-00007
PROBECHEK UROVYSION CONTROL SLIDESSep 8, 2010
MalfunctionAbbott Molecular, Inc.3005248192-2010-00003

Event type breakdown

Malfunction6

Most-reported manufacturers

Abbott Molecular, Inc.6

Recalls

1 recall events for this product code

Vysis
TerminatedJul 20, 2004
ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fix
Some of the control slides did not have adequate cells deposited upon their surface.
Z-0640-04 · View FDA record ↗

Registered firms

5 firms currently registered for this product code

510(k) clearances

9 clearances for this product code