Recall Z-1446-2012 ยท DJR Enzyme Immunoassay, Methadone
Alere San Diego dba Biosite Innovacon Hemosense Inc
Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, incl
| Date | Apr 20, 2012 (initiated Mar 12, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen. |
| Root cause | Nonconforming Material/Component |
| Action | Biosite sent a "PRODUCT ADVISORY NOTICE" letter dated March 12, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter states that customers may continue to use the product. Customers were instructed to complete and fax an enclosed verification form to Technical Services at 1-858-695-7100. Customers with any questions about the information contained in the notification were instructed to contact Biosite Inc. at (888) 246-7483. |
| Quantity | 1,258,002 kits |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada and European Union. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 Biosite Incorporated, Jun 22, 2006 |