Events

Retiro De Equipo (Recall) de Device Recall Drugs of Abuse Screen

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Alere San Diego.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60980
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1130-2012
  • Fecha de inicio del evento
    2012-01-04
  • Fecha de publicación del evento
    2012-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106984
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme immunoassay, barbiturate - Product Code DIS
  • Causa
    Alere san diego received a rise in customer complaints regarding false positive barbiturates (bar) results on the triage drugs of abuse panel plus tca.
  • Acción
    Alere sent a "PRODUCT NOTIFICATION" letter dated January 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return to the firm. Contact Technical Services at 1-877-308-8287.

Device

Device Recall Drugs of Abuse Screen
  • Modelo / Serial
    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
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, EU, Guatemala, Japan, Lebanon, and Saudi Arabia.
  • Descripción del producto
    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.
  • Manufacturer
    Alere San Diego

Manufacturer

Alere San Diego
  • Dirección del fabricante
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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.
  • Source
    USFDA