Alere San Diego, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0418-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 14, 2017

Date Posted: February 7, 2018

Recall Number: Z-0418-2018

Event ID: 78608

Reason for Recall:

The recalled lots have demonstrated unexpected false positive THC results.

Status: Completed

Product Quantity: 2940 units

Code Information:

Lots 403111, 406741, 396588, 398577, 396587

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated