PlainRecalls
FDA Devices Moderate Class II Terminated

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 t

Reported: October 17, 2012 Initiated: May 28, 2009 #Z-0029-2013

Product Description

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.

Reason for Recall

Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.

Details

Recalling Firm
Alere San Diego, Inc.
Units Affected
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 Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, and Uruguay.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Alere San Diego, Inc.. Units affected: 45,638 units.
Why was this product recalled? ▼
Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0029-2013.

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