Recall Z-2039-2012 ยท DJR Enzyme Immunoassay, Methadone
Alere San Diego, Inc.
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, b
| Date | Jul 19, 2012 (initiated May 14, 2012) |
| Status | Terminated |
| Reason | A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen. |
| Root cause | Nonconforming Material/Component |
| Action | Alere sent an Urgent Medical Device Recall letter dated June 11, 2012 to all affected customers. The letter informed the customers of the affected product, problem identified and actions to be taken. Customers were instructed to discontinue all use of the recalled lots, immediately inform clinicians of this recall at the testing site(s) and complete and fax the enclosed customer verification form and list of affected lots within 10 days to confirm receipt of the letter. Customers with questions about the information contained in the recall letter, can contact Alere San Diego at 9975 Summer |
| Quantity | 9,997 kits |
| Distribution | US Nationwide Distribution |
| 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 |