Events

Retiro De Equipo (Recall) de Device Recall VITEK 2 Compact 30

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
    77799
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3076-2017
  • Fecha de inicio del evento
    2017-07-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157919
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Customers have reported that some vitek¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. the issue was reported to occur on vitek¿ 2 compact 15 and compact 30 systems following a system software update to version 8.01.
  • Acción
    Consignees (Subsidiaries) of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on 07/12/2017. The direct consignees (subsidiaries and distributors) have until 08/12/2017 to notify their respective impacted users. The directions to the user are as follows: Please implement the following actions at this time: " Confirm this letter has been distributed to, and reviewed by, all appropriate personnel within your organization. " Refrain from performing the VITEK¿ 2 Systems Software 8.01 update. o A solution has been identified, and your local bioM¿rieux representative will contact you with further instruction in the coming weeks. " If you have updated VITEK¿ 2 Systems Software to version 8.01 within the last seven (7) days, please contact your local bioM¿rieux representative. " Please store this letter with your bioM¿rieux instrument documentation. " Complete the Acknowledgement Form and return it to your local bioM¿rieux representative."

Device

Device Recall VITEK 2 Compact 30
  • Modelo / Serial
    VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide
  • Descripción del producto
    VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
  • 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