FDA Device recall Z-0418-2018
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591
- FDA Device
- Class II
- completed
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591 by Alere San Diego, citing the recalled lots have demonstrated unexpected false positive THC results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0418-2018 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-11-14 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alere San Diego |
| Distribution | US |
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.
Reason
The recalled lots have demonstrated unexpected false positive THC results.
Identifiers
| code_info | Lots 403111, 406741, 396588, 398577, 396587 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.