Recall Z-0289-06 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Bio-Rad Laboratories Inc
Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223
| Date | Dec 15, 2005 (initiated Jun 4, 2004) |
| Status | Terminated |
| Reason | The device was producing false negative results for cocaine tests. |
| Root cause | Other |
| Action | Phone calls and faxed notification forms were sent to all customers on June 4, 2004. Outside the US, subsidiaries were notified via e-mail with forms to be completed. |
| Quantity | 384 units |
| Distribution | 60 consignees received the product in the US and 6 international consignees received the product. Distribution is limited to the following countries: Canada, France, UK, Germany and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.