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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 20, 2003
Date Posted September 23, 2003
Recall Status1 Terminated 3 on September 22, 2003
Recall Number Z-1246-03
Recall Event ID 27074
Product Classification Enzyme Immunoassay, Cocaine And Cocaine Metabolites - Product Code DIO
Product Drug Check 4 Test Cup AMP/COC/OPI/THC

Product Code 60400, and 60410
Code Information All codes
Recalling Firm/
Drug Free Enterprises Inc
5302 Derry Ave., Ste A
Agoura Hills CA 91301
Manufacturer Reason
for Recall
Label lacks professional use legend and name and address of the manufacturer.
FDA Determined
Cause 2
Action The firm sent a letter to customers requesting that they overlabel their stock on 3/20/2003. This recall is complete.
Quantity in Commerce Undetermined.
Distribution Nationwide
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.