Triage Drugs of Abuse Plus TCA 25 Test Kit — Class II medical device recall Z-0418-2018
Completed recall by Alere San Diego, Inc., reported 2018-02-07, distributed nationwide. The recalled lots have demonstrated unexpected false positive THC results.
| Recall number | Z-0418-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2017-11-14 |
| Classified | 2018-01-26 |
| Reported by FDA | 2018-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 2,940 units |
| Lot numbers | 396587, 396588, 398577, 403111, 406741 |
| Model numbers | 92000, 92590, 92591 |
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 for recall
The recalled lots have demonstrated unexpected false positive THC results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0418-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.