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.
Z-0418-2018
Product summary
- Event
- Event 78608
- Status
- Completed
- Classification
- Class II
- Quantity
- 2940 units
- Official record key
device-enforcement:Z-0418-2018
Official wording
Reason: The recalled lots have demonstrated unexpected false positive THC results.
Code information: Lots 403111, 406741, 396588, 398577, 396587
Distribution pattern: Worldwide distribution - United States Nationwide and the countries of Japan, Canada
Derived failure modes
-
Unknown
The recalled lots have demonstrated unexpected false positive THC results.