Recall Z-2202-2008 ยท DKZ Enzyme Immunoassay, Amphetamine
Medtox Diagnostics Inc
MEDTOXscan Reader
| Date | Sep 26, 2008 (initiated Feb 8, 2008) |
| Status | Terminated |
| Reason | Reader was marketed without a 510(k). |
| Root cause | Other |
| Action | 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 t |
| Quantity | 391 Readers |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.