Recall Z-1254-03 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Drug Free Enterprises Inc
DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/TCA Product Code 60900
| Date | Sep 23, 2003 (initiated Mar 20, 2003) |
| Status | Terminated |
| Reason | Label lacks professional use legend and name and address of the manufacturer. |
| Root cause | Other |
| Action | The firm sent a letter to customers requesting that they overlabel their stock on 3/20/2003. This recall is complete. |
| Quantity | Undetermined. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.