Alere Triage Drugs of Abuse Plus TCA 25 Test Kit Recalled for False Positives
Alere San Diego, Inc. is recalling specific lots of the Triage Drugs of Abuse Plus TCA 25 Test Kit because they produced unexpected false positive THC results.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves diagnostic inaccuracy (false positives) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Alere San Diego, Inc. is recalling the Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, and 92591. The affected units are identified by Lots 403111, 406741, 396588, 398577, and 396587. A total of 2,940 units were distributed nationwide in the United States, as well as in Japan and Canada.
The recall was initiated because the recalled lots demonstrated unexpected false positive THC results. This product is a diagnostic test kit used for the simultaneous detection and identification of major drugs and their urinary metabolites.
Users of the affected test kits should stop using the product and contact Alere San Diego, Inc. for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 2,940
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots 403111
- 406741
- 396588
- 398577
- 396587
Distribution
Distributed nationwide across the United States.
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