Recall Z-0418-2018
Alere San Diego, Inc. · initiated November 14, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lots 403111, 406741, 396588, 398577, 396587
Reason for recall
The recalled lots have demonstrated unexpected false positive THC results.
FDA-determined cause: Nonconforming Material/Component
Action taken
All primary consignees will be contacted in letter provided via fax, email or direct mail. End users will be instructed to discard any remaining inventory they may have of the affected lots. Alere will provide credit to end users for any remaining unused inventory.
Details
- Recall number
- Z-0418-2018
- Initiated
- November 14, 2017
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Quantity
- 2940 units
- Distribution
- Worldwide distribution - United States Nationwide and the countries of Japan, Canada
- Recalling firm
- Alere San Diego, Inc., San Diego, CA