Worldwide Distribution - USA (nationwide) and Internationally to Taiwan.
Description du dispositif
Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. || 25 individually pouched devices in a labeled kit box. || Indications for use: The 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.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
Part 90008: lot 259403 exp 02/03/13, lot 267081 exp 05/08/13 Part 92000: lots 254662, 255830, 257527, 262143 with exp 01/06/13; lots 259628, 259954 with exp 02/03/13 Part 92002: lot 234295 exp 02/03/13
Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, EU, Guatemala, Japan, Lebanon, and Saudi Arabia.
Description du dispositif
Product Brand Names: Triage¿ Drugs of Abuse Panel 8 Test Kit (K924476), Triage¿ Drugs of Abuse || Panel Plus TCA (K973784), & Triage¿ Drugs of Abuse Panel Plus PPX (K014247) || Model Number: 90008, 92002, & 92000 || Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices || in a labeled kit box. || The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry, || ASCENDTM MULTIMMUNOASSAY¿ (AMIATM). Each AMIATM assay is a competitive binding immunoassay || in which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine for || antibody binding sites. After a brief incubation, the reaction mixture is transferred to the membrane in the || Detection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine, binds to a || zone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove the || unbound conjugate and clear the background. Test results are visually read. || The Triage¿ Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, (Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates), and Tricyclic Antidepressants in urine.