Events

Retiro De Equipo (Recall) de Device Recall Vitek 2 ASTP635 REF 416 911

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 Biomerieux 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
    70645
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1401-2015
  • Fecha de inicio del evento
    2015-02-25
  • Fecha de publicación del evento
    2015-04-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134235
  • 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
    Susceptibility test cards, antimicrobial - Product Code LTW
  • Causa
    The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
  • Acción
    Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in the Package Insert antibiotic table to confirm which organisms can be tested. " Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae. " Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms. " Please store this letter with your bioM¿rieux instrument documentation. Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc. Customers with questions were instructed to contact their local BioMerieux representative. For questions regarding this recall call 314-731-8526.

Device

Device Recall Vitek 2 ASTP635 REF 416 911
  • Modelo / Serial
    lot 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
  • Descripción del producto
    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • Dirección del fabricante
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA