PlainRecalls
FDA Devices Moderate Class II Completed

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

Reported: February 7, 2018 Initiated: November 14, 2017 #Z-0418-2018

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.

Details

Recalling Firm
Alere San Diego, Inc.
Units Affected
2940 units
Distribution
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
Location
San Diego, CA

Frequently Asked Questions

What product 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.. Recalled by Alere San Diego, Inc.. Units affected: 2940 units.
Why was this product recalled? ▼
The recalled lots have demonstrated unexpected false positive THC results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0418-2018.

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