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U.S. Department of Health and Human Services

Class 3 Device Recall ProbeChek UroVysion Control Slides

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  Class 3 Device Recall ProbeChek UroVysion Control Slides see related information
Date Initiated by Firm February 19, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 27, 2004
Recall Number Z-0640-04
Recall Event ID 28384
510(K)Number K011031  K013785  
Product Classification System, Test, Tumor Marker, Monitoring, Bladder - Product Code MMW
Product 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
Code Information catalog #30-805070, lot 47228, exp. 05/04 and lot 49023, exp. 08/04
Recalling Firm/
Manufacturer		 Vysis
3100 Woodcreek Dr
Downers Grove IL 60515-5427
For Additional Information Contact Mr. Syed Ataullah
630-271-7045
Manufacturer Reason
for Recall		 Some of the control slides did not have adequate cells deposited upon their surface.
FDA Determined
Cause 2		 Other
Action Vysis telephoned their customers who received the two affected lots of slides beginning on 2/18/04, informing them of the complaints of missing cells on the control slides. The accounts were requested to check their stocks for any remaining slides from these two lots and return them to Vysis for replacement.
Quantity in Commerce 234 kits
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MMW and Original Applicant = VYSIS
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