Events

Retiro De Equipo (Recall) de Device Recall Influenza Transport Swab

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 Quidel Corporation.

¿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
    76337
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1231-2017
  • Fecha de inicio del evento
    2017-01-25
  • Fecha de publicación del evento
    2017-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152840
  • 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
    Respiratory virus panel nucleic acid assay system - Product Code OCC
  • Causa
    Quidel corporation is recalling influenza transport swab packages because it may include an incorrect sample swab mixed in with the proper swabs.
  • Acción
    Quidel sent an Urgent Medical Device Recall letter dated 1/25/17 to all affected customers and distributors to inform them that Quidel is recalling the Influenza Transport Swab Packages because they may contain incorrect sample swab mixed in with the proper swabs. The letter informs the customers that the standard influenza swab is packaged individually, one (1) swab per package and uses a polyurethane foam tip. The incorrect swab is packaged as two (2) swabs per individual package and uses a rayon fiber tip. Customers are instructed to complete the enclosed Inventory Assessment/Certificate of Destruction form and return to Quidel. Contact Quidel Technical Support at technicalsupport@quidel.com or by calling 800.874.1517 (in the U.S.), or 858.552.1100 (outside the U.S.), for instructions on how to obtain replacement product. Our hours of operation are Monday through Friday, 7:00 a.m. to 5:00 p.m. Pacific Time.

Device

Device Recall Influenza Transport Swab
  • Modelo / Serial
    PS10171
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
  • Descripción del producto
    Influenza Transport Swab Packages, Reference #20171, || One lot with 1010 packages (each package contains 25 transport tubes). || The Influenza Swabs in dry transport tubes are intended for use with influenza tests
  • Manufacturer
    Quidel Corporation

Manufacturer

Quidel Corporation
  • Dirección del fabricante
    Quidel Corporation, 10165 McKellar Ct, San Diego CA 92121-4201
  • Empresa matriz del fabricante (2017)
    Quidel Corporation
  • Source
    USFDA