Reported Jul 25, 2012 · Terminated
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence…
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?
- Alere Triage Tox+MTD Drug Screen
- PN 94400 Product UsageThe Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the 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. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results
- Lot codes and dates
- Lot/Unit Codes
W50216BW50222BW50245BW50250BW50809BW50810BW50812BW50813BW50816BW50817BW50818BW50819BW50820BW50821BW50822BW50823BW50826BW50829BW50830BW50831BW50832BW50837BW50838BW50842BW50843BW50844BW50846BW50848BW50851BW50862BW50866BW50869BW50870BW50871BW50872BW50873B
- Lot/Unit Codes
- Amount recalled
- 9,997 kits
Where it was sold
- Nationwide
Why it was recalled
A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.
This product could cause temporary or reversible health problems — stop using it.
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