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U.S. Department of Health and Human Services

Class 2 Device Recall MEDTOXscan

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 Class 2 Device Recall MEDTOXscansee related information
Date Initiated by FirmFebruary 08, 2008
Date PostedSeptember 26, 2008
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-2202-2008
Recall Event ID 47501
Product Classification Amphetamine enzyme immunoassay - Product Code DKZ
ProductMEDTOXscan Reader
Code Information Product number 833062
FEI Number 1050155
Recalling Firm/
Manufacturer		 Medtox Diagnostics Inc
1238 Anthony Rd
Burlington NC 27215-8936
For Additional Information ContactSusan Puskas
651-628-6108
Manufacturer Reason
for Recall		Reader was marketed without a 510(k).
FDA Determined
Cause 2		Other
ActionConsignees were notified by telephone starting 02/08/2008. They were being read the following script.: This is (company representative) calling regarding the MEDTOXscan Reader , Serial Number #######, that we sent to you on (date). Based on recent discussions with the FDA it has been determined that the reader should have had FDA clearance prior to MEDTOX marketing the reader. Since the MEDTOXscan Reader was marketed without 510(k) clearance it is considered mis-branded. MEDTOX is voluntarily recalling all readers until we receive this clearance. The PROFILE III ER devices sold for use with the readers are appropriately cleared by the FDA, and can be read visually, independent of the reader and therefore are not affected by the recall. Please discontinue using the reader immediately. We will send you shipping materials and instructions on how to return the reader to MEDTOX. You will receive these materials within the next 7 days and we request that you return the reader to MEDTOX within 5 days. Your assistance is appreciated and necessary. The Food and Drug Administration is aware of this recall.
Quantity in Commerce391 Readers
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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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