CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Triage Drugs of Abuse Plus TCA 25 Test Kit recalled by Alere San Diego
Alere San Diego is recalling Triage Drugs of Abuse Plus TCA 25 Test Kit, distributed nationwide in the US. The recall was initiated on 14 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0418-2018
- FDA event ID
- 78608
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 14 Nov 2017
- FDA classified
- 26 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Nov 2017 | Recall initiated by company | |
| 26 Jan 2018 | Classified by FDA | +73 days |
| 7 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recalled lots have demonstrated unexpected false positive THC results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
Questions about this recall
Why was it recalled?
The recalled lots have demonstrated unexpected false positive THC results.
Which lots are affected?
Lots 403111, 406741, 396588, 398577, 396587
Where was it sold?
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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