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Alere San Diego, Inc. recalls Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassa
Recalled October 17, 2012 · FDA recall Z-0029-2013 · Alere San Diego
Hazard
Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled. · FDA Class II
Units
45,638 units
Sold at
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 Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, and Uruguay.
Description
Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
Product
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, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Manufacturer(s)
Alere San Diego, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →