FDA recall Z-0418-2018

Alere San Diego, Inc. · Class II · device

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.

Reason for recall

The recalled lots have demonstrated unexpected false positive THC results.

Distribution

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

Key facts

Status
Completed
Initiation date
2017-11-14
Report date
2018-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0418-2018