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Alere San Diego, Inc. recalls Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle
Recalled February 7, 2018 · FDA recall Z-0418-2018 · Alere San Diego
Hazard
The recalled lots have demonstrated unexpected false positive THC results. · FDA Class II
Units
2940 units
Sold at
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
Description
The recalled lots have demonstrated unexpected false positive THC results.
Product
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.
Manufacturer(s)
Alere San Diego, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →