Medtox Diagnostics Inc MEDTOXscan Reader Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEDTOXscan Reader
Brand
Medtox Diagnostics Inc
Lot Codes / Batch Numbers
Product number 833062
Products Sold
Product number 833062
Medtox Diagnostics Inc is recalling MEDTOXscan Reader due to Reader was marketed without a 510(k).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reader was marketed without a 510(k).
Recommended Action
Per FDA guidance
Consignees 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026