| Class 3 Device Recall ProbeChek UroVysion Control Slides | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MMW
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