Events

Retiro De Equipo (Recall) de Device Recall VITEK 2 GP ID Test card

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
    77935
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3134-2017
  • Fecha de inicio del evento
    2017-08-25
  • 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=158270
  • 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
    Gram positive identification panel - Product Code LQL
  • Causa
    Customer reports have indicated occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc(r) 700327(tm) in association with vitek(r) 2 gp id lot 2420240403 and 2420303403, causing failure of the quality control (qc) testing for the vitek(r) 2 gp id card. the expected o129r reaction for atcc¿ 700327(tm) strain is positive.
  • Acción
    bioMerieux sent an Urgent Product Removval Notice to all affected consignees (Subsidiaries) of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on August 25, 2017. . The directions to the user are as follows: "Please implement the following actions at this time: We request you take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Please refrain from using the referenced test kits (VITEK¿ 2 GP ID, Lots 2420240403 and 2420303403) in your laboratory. Destroy any of this product in your inventory, and contact your local bioM¿rieux representative for credit or replacement. " Please store this letter with your bioM¿rieux system documentation. " Complete the attached Acknowledgement Form and return it to your local bioM¿rieux representative." Consignees with questions were instructed to contact their local representative.

Device

Device Recall VITEK 2 GP ID Test card
  • Modelo / Serial
    Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany, Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia, Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom
  • Descripción del producto
    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. || VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
  • 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