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U.S. Department of Health and Human Services

Class 2 Device Recall PROFILEV MEDTOXScan Drugs of Abuse Test System

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  Class 2 Device Recall PROFILEV MEDTOXScan Drugs of Abuse Test System see related information
Date Initiated by Firm April 05, 2013
Date Posted May 16, 2013
Recall Status1 Terminated 3 on September 12, 2013
Recall Number Z-1329-2013
Recall Event ID 64800
510(K)Number K080635  
Product Classification Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
Product PROFILE-V MEDTOXScan Drugs of Abuse Test System.

For the rapid, qualitative detection of drugs of abuse in human urine,
Code Information Part No. 604018 - Lot No. 6821, 6822, 6823, 6824, 6825, 6831, 6832, 6841, 6851, 6852, 6853, 6861, 6862, 6863, 6864, 6865, 6866, 6867, 6868, 6871, 6881, 6891, 6892, 6901, 6902, 6903, 6904, 6911, 6912, 6921, 6922, 6931, 6942; Part No. 604019 - Lot No. 6321, 6331, 6341, 6351; Part No. 604020 - Lot No. 6361, 6371; Part No. 604022 - Lot No. 6551, 6552, 6561, 6562, 6563, 6564, 6571, 6581, 6582, 6583, 6584, 6591, 6592, 6593, 6601, 6602, 6603, 6611, 6612, 6621, 6622, 6623, 6631, 6632, 6641, 6651, 6652, 6661, 6671, 6672, 6681; Part No. 604026 - Lot No. 6041, 6051; Part No. 604028 - Lot No. 6051, 6061, 6071, 6081, 6091,
Recalling Firm/
Manufacturer		 Medtox Diagnostics Inc
1238 Anthony Rd
Burlington NC 27215-8936
For Additional Information Contact Beth Brock
336-226-6311 Ext. 2862
Manufacturer Reason
for Recall		 Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action MEDTOX issued "URGENT MEDICAL DEVICE RECALL" letters dated April 3, 2013 to consignees informing them of the recall. The letter requested that they examine their inventory and immediately discontinue all use and distribution of the affected lots. The letter also requested that they immediately inform clinicians of the recall at the testing sites that have utilized the recall product. The letter also included a Customer Verification Form which was to be returned.
Quantity in Commerce 221,625
Distribution Worldwide distribution: USA (nationwide) and in the country of: Canada.
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 = DIO and Original Applicant = MEDTOX DIAGNOSTICS, INC.
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