Food, drugs, devices › Alere San Diego, Inc.
Device recall: Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle
Alere San Diego, Inc. (San Diego, CA) initiated this device recall on 14 Nov 2017; FDA lists 1 product record under event 78608, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Alere San Diego, Inc. has 28 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Alere San Diego, Inc., San Diego, CA.
Reason for recall
"The recalled lots have demonstrated unexpected false positive THC results."
Distribution
"Worldwide distribution - United States Nationwide and the countries of Japan, Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0418-2018 | 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… | 2940 units | Class II | Completed | 7 Feb 2018 |
Context
Other enforcement events for Alere San Diego, Inc.
All 28 events for Alere San Diego, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The recalled lots have demonstrated unexpected false positive THC results."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - United States Nationwide and the countries of Japan, Canada"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.