Devices

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
Manufacturer
Vysis
1 Event
- Recall of Device Recall ProbeChek UroVysion Control Slides

Manufacturer

Vysis

Manufacturer Address
Vysis, 3100 Woodcreek Dr, Downers Grove IL 60515-5427
Source
USFDA

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