Events

Retiro De Equipo (Recall) de Device Recall bioMerieux Vitek 2 Systems Software version 6.01 software

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
    65470
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1914-2013
  • Fecha de inicio del evento
    2013-06-14
  • Fecha de publicación del evento
    2013-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120031
  • 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
    A product issue has been identified for customers using software version 6.01 and are interfaced with a laboratory information system (lis). during the update of software from version 5.Xx to 6.01, the bid-directional computer interface (bci) antibiotic codes are not updated properly for cefovecin, prulifloxacin and ceftaroline. for the referenced antibiotics, the firm code in the reference table.
  • Acción
    The firm, bioMerieux, sent an "Urgent Product Correction Notice" letter dated June 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure the Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes are distributed to all appropriate personnel in your organization; follow the instructions in the attached file (Instructions for modifying BCI Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table and complete and return the Attachment A: Acknowledgement Form via Fax to: Attn: RA North American ComOps at (919)287-2542. If you require additional assistance or have any questions, please contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666 or Industrial Customer Service organization at (800) 634-7656.

Device

Device Recall bioMerieux Vitek 2 Systems Software version 6.01 software
  • Modelo / Serial
    version 6.01
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
  • Descripción del producto
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. || The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing 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