Recall Z-0029-2013 ยท DJR Enzyme Immunoassay, Methadone
Alere San Diego, Inc.
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: 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, including assays for acetaminophen/paracetamol, amphetamines, metha
| Date | Oct 10, 2012 (initiated May 28, 2009) |
| Status | Terminated |
| Reason | Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled. |
| Root cause | Error in labeling |
| Action | Biosite sent a Notice of Correction letter dated May 28, 2009 to all their customers who purchased the Triage TOX Drug Screen. The letter informed the customers of the problem identified and actions to be taken. Customers are instructed that performance of Triage TOX Drug Screen test devices is not affected in any way by the misprinted box flap, provided the test is used with a urine sample as per the instructions for use. Customers are instructed to complete and fax the enclosed verification form within 10 days. In the US, customers were instructed to contact Biosite at (877) 441-7440 or |
| Quantity | 45,638 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Finlind, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, India, Indonesia, Italy, Lebanon, Mexico, Netherlands, Norway, Puerto Rico, Romania, Saudi Arabia, South A |
| 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 |