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.
Enforcement
- Recall Number
- Z-0418-2018
- Event ID
- 78608
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Alere San Diego, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 7, 2018
- Initiation Date
- November 14, 2017
- Classification Date
- January 26, 2018
- Address
- 9975 Summers Ridge Rd, San Diego, CA, 92121-2997, United States
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.
The recalled lots have demonstrated unexpected false positive THC results.
Lots 403111, 406741, 396588, 398577, 396587
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
2940 units