Events

Retiro De Equipo (Recall) de Device Recall Triage Drugs of Abuse Panel

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 Biosite Inc.

¿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
    50689
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1088-2009
  • Fecha de inicio del evento
    2008-11-06
  • Fecha de publicación del evento
    2009-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75998
  • 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
    Amphetamine Enzyme Immunoassay - Product Code DKZ
  • Causa
    The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive pcp results has exceeded their post market surveillance thresholds for customer complaints in the field. in addition, the firm has been able to reproduce false positive results reported by customers and as a result.
  • Acción
    Consignee notification was initiated on 11/6/2008 with Urgent Medical Device Recall notifications, dated 11/5/2008 and mailed to domestic customers sent via US Postal Service Priority Mail and to foreign customers via FedEx. The notice informed customers of the reason for the recall and requested the customers immediately discontinue all use of lot #186625 and discard all affected product in accordance with your local regulations. The customers were also instructed to complete and fax an attached Customer/Distributor Verification form within 10 days.

Device

Device Recall Triage Drugs of Abuse Panel
  • Modelo / Serial
    Lot/Unit Codes: 186625
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and country of Canada.
  • Descripción del producto
    Triage Drugs of Abuse Panel, Model Number: 95000. || Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.
  • Manufacturer
    Biosite Inc

Manufacturer

Biosite Inc
  • Dirección del fabricante
    Biosite Inc, 9975 Summers Ridge Rd, San Diego CA 92121
  • 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