Recall Z-0418-2018 ยท DKZ Enzyme Immunoassay, Amphetamine
Alere San Diego, Inc.
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs
| Date | Nov 14, 2017 |
| Status | Completed |
| Reason | The recalled lots have demonstrated unexpected false positive THC results. |
| Root cause | Nonconforming Material/Component |
| Action | All primary consignees will be contacted in letter provided via fax, email or direct mail. End users will be instructed to discard any remaining inventory they may have of the affected lots. Alere will provide credit to end users for any remaining unused inventory. |
| Quantity | 2940 units |
| Distribution | Worldwide distribution - United States Nationwide and the countries of Japan, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973784 | TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS Biosite Incorporated, Dec 3, 1997 |