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Lower risk Medical device recall · FDA · Published November 14, 2017

Alere Triage Drugs of Abuse Plus TCA 25 Test Kit: False Positive THC Results

Alere recalls Triage Drugs of Abuse Plus TCA 25 Test Kits with model numbers 92000, 92590, 92591 due to unexpected false positive THC results. Affected kits may show incorrect drug test results.

🇺🇸 FDA recall #Z-0418-2018Medical deviceAlere ›
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Contact the company

Recalling firmAlere San Diego, Inc.9975 Summers Ridge Rd · San Diego, CA 92121-2997
✎ GovInfoNow plain-language explainer

Alere is recalling specific drug test kits that may give false positive results for THC. This could lead to incorrect drug test outcomes, which might affect legal or medical decisions. Read more at govinfonow.com/recall/72542-alere-triage-drugs-of-abuse-plus-tca-25-test-kit.

Source Summary by GovInfoNow · govinfonow.com/recall/72542-alere-triage-drugs-of-abuse-plus-tca-25-test-kit · Updated September 1, 2026 · FDA enforcement record: FDA #Z-0418-2018

Cite this page

“Alere Triage Drugs of Abuse Plus TCA 25 Test Kit: False Positive THC Results.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72542-alere-triage-drugs-of-abuse-plus-tca-25-test-kit. Based on FDA recall #Z-0418-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2018%22&limit=1).

The FDA announced on 2017-11-14 that Alere San Diego, Inc. is recalling Triage Drugs of Abuse Plus TCA 25 Test Kits due to unexpected false positive THC results. Owners should contact the company for a replacement.

How to tell if you have it

  • Brand: Alere
  • Product: Triage Drugs of Abuse Plus TCA 25 Test Kit
  • Model Numbers: 92000, 92590, 92591
  • Lot Codes: 403111, 406741, 396588, 398577, 396587

The hazard

The recalled lots have demonstrated unexpected false positive THC results. According to the FDA, this may lead to incorrect drug screening outcomes.

Context

GovInfoNow's records show Alere San Diego, Inc. has 4 other recalls on record since 2019-02-15. Other recent recalls of similar products include Tosoh ST AIA-Pack Testosterone Recall (2026-06-12), Siemens Atellica CH Urine Albumin Recall (2026-07-06), and Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24).

How to tell if you have this one

Check the model number on the kit box: 92000, 92590, or 92591. The kits come with 25 individually pouched devices, a bottle of wash solution, a pipette, and 50 pipette tips.

  • Brand
    Alere
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Look for model numbers 92000, 92590, or 92591 on the kit box.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - United States Nationwide and the countries of Japan, Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Nov 14, 201712. FDA classified it Class II: Jan 26, 201823. Published in FDA’s Enforcement Report: Feb 7, 2018320172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0418-2018 (November 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0418-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 1, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA