Recall Z-1419-2018 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
OraSure Technologies, Inc.
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
| Date | Dec 20, 2017 |
| Status | Terminated |
| Reason | The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control. |
| Root cause | Under Investigation by firm |
| Action | The email to the firm's consignees states the controls will be replaced. |
| Quantity | 10 |
| Distribution | Distributed to 2 consignees in KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982061 | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) OraSure Technologies, Inc., Aug 25, 1998 |