Alere San Diego, Inc. recalls Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottl…

Recall date

November 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0418-2018

FDA classification

Class II

Brand / firm

Alere San Diego, Inc.

Sold / distributed

Worldwide distribution - United States Nationwide and the countries of Japan, Canada

Why it was recalled

The recalled lots have demonstrated unexpected false positive THC results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.