Home / Recalls / Alere San Diego, Inc. / Z-0418-2018

Z-0418-2018 Class II

Recalled by Alere San Diego, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
February 7, 2018
Initiation Date
November 14, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2940 units

Product Description

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.

Reason for Recall

The recalled lots have demonstrated unexpected false positive THC results.

Distribution Pattern

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

Code Information

Lots 403111, 406741, 396588, 398577, 396587

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