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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 December 18, 2003
Recall Status1 Terminated 3 on December 17, 2003
Recall Number Z-0239-04
Recall Event ID 27817
Product Classification Enzyme Immunoassay, Cocaine And Cocaine Metabolites - Product Code DIO
Product DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
Code Information All Codes.
Recalling Firm/
Manufacturer		 Drug Free Enterprises Inc
5302 Derry Ave Ste A
Agoura Hills CA 91301-6022
For Additional Information Contact Feng-Yu Lee
818-707-4111
Manufacturer Reason
for Recall		 Lacks professional use labeling and firm name and address.
FDA Determined
Cause 2		 Other
Action Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.
Quantity in Commerce 2800 units
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.
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