Events

Retiro De Equipo (Recall) de VITEK 2 GN ID

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
    77026
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2341-2017
  • Fecha de inicio del evento
    2017-04-20
  • Fecha de publicación del evento
    2017-05-22
  • 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=154843
  • 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 negative identification panel - Product Code LQM
  • Causa
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Acción
    The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.

Device

VITEK 2 GN ID
  • Modelo / Serial
    241396010 17/Oct/17 241398120 07/Nov/17 241398420 10/Nov/17 241398620 12/Nov/17 241398720 13/Nov/17 241398820 14/Nov/17 241399520 21/Nov/17 2410000203 26/Nov/17 2410002203 28/Nov/17 2410006203 02/Dec/17 2410007203 03/Dec/17 2410008203 04/Dec/17 2410009103 05/Dec/17 2410031103 27/Dec/17 2410033103 29/Dec/17 2410034103 30/Dec/17 2410037103 02/Jan/18 2410038103 03/Jan/18 2410041103 06/Jan/18 2410042103 07/Jan/18 2410043103 08/Jan/18 2410044203 09/Jan/18 2410047203 12/Jan/18 2410052103 17/Jan/18 2410057103 22/Jan/18 2410058103 23/Jan/18 2410063103 28/Jan/18 2410064103 29/Jan/18 2410065103 30/Jan/18 2410071103 05/Feb/18 2410072103 06/Feb/18 2410078103 12/Feb/18 2410083103 17/Feb/18 2410085203 19/Feb/18 2410086103 20/Feb/18 2410088103 22/Feb/18 2410091203 25/Feb/18 2410092103 26/Feb/18 2410093103 27/Feb/18 2410097103 03/Mar/18 2410098103 04/Mar/18 2410099103 05/Mar/18 2410100103 06/Mar/18 2410105203 11/Mar/18 2410106103 12/Mar/18 2410107203 13/Mar/18
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
  • 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