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.
Recall
- Recall Number
- Z-0029-2013
- Event Number
- 63175
- Firm
- Alere San Diego, Inc.
- FEI Number
- 1000125596
- Product Code
- DJR
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- May 28, 2009
- Posted
- October 10, 2012
- Terminated
- October 10, 2012
- Address
- 9975 Summers Ridge Rd, San Diego, CA, 92121-2997
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.
Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
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 email [email protected]. Customers in UK are instructed to contact European Representative, Lesley Paice, [email protected].
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.
45,638 units