Z-0418-2018 Class II
FDA device recall Z-0418-2018 was initiated by Alere San Diego, Inc. on Nov 14, 2017 and is designated Class II. Reason for recall: The recalled lots have demonstrated unexpected false positive THC results. Affected quantity: 2940 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 7, 2018
- Initiation Date
- Nov 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2940 units
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.
Distribution Pattern
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
Code Information
Lots 403111, 406741, 396588, 398577, 396587
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0418-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026