# FDA recall Z-0418-2018

> **Alere San Diego, Inc.** · Class II · device recall initiated 2017-11-14.

## 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

- **Recall number:** Z-0418-2018
- **Recalling firm:** Alere San Diego, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0418-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0418-2018. Source: US FDA. Licensed CC0.

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