Reported Oct 17, 2012 · Terminated

Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay…

Alere San Diego, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997

Is this the product you have?

  • Triage TOX Drug Screen Panel, Model# 94400
  • Product UsageThe Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine
Lot codes and dates
  • Lot Numbers

    188 of 188 codes

    • W42932B
    • W42933B
    • W42934B
    • W42935B
    • W43279B
    • W43281B
    • W43282B
    • W43283B
    • W43284B
    • W43285B
    • W43286B
    • W43287B
    • W43288B
    • W43637B
    • W43638B
    • W43640B
    • W43646B
    • W43648B
    • W43649B
    • W43650B
    • W43652B
    • W43653B
    • W43655B
    • W43657B
    • W43659B
    • W43660B
    • W43661B
    • W43663B
    • W43664B
    • W43665B
    • W43692B
    • W43693B
    • W43694B
    • W43695B
    • W43696B
    • W43697B
    • W43698B
    • W43699B
    • W43700B
    • W43701B
    • W43702B
    • W43703B
    • W43704B
    • W43705B
    • W43706B
    • W43707B
    • W43708B
    • W43709B
    • W43710B
    • W43711B
    • W43712B
    • W43713B
    • W43714B
    • W43715B
    • W43716B
    • W43717B
    • W43718B
    • W43983B
    • W43984B
    • W43985B
Amount recalled
45,638 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 10, 2012 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.