International Medical Devices Database

Manufacturer Address
Vysis, 3100 Woodcreek Dr, Downers Grove IL 60515-5427
Source
USFDA
1 Event
- Recall of Device Recall ProbeChek UroVysion Control Slides

One device in the database

Device Recall ProbeChek UroVysion Control Slides

Model / Serial
catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
DOmestically to accounts in Michigan, South Carolina, Illinois, Ohio, Connecticut, Arizona, New York, Texas, California, Oklahoma, Maryland, Virginia, Utah, Florida, Louisiana, Montana, Arkansas, Massachusetts, Minnesota, Missouri and North Carolina, and internationally to Germany and Japan.
Product Description
ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers Grove, IL 60515 USA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Vysis

One device in the database

Device Recall ProbeChek UroVysion Control Slides