Events

Retiro De Equipo (Recall) de MicroVue Bb Plus EIA

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 Diagnostic Hybrids 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
    69545
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0417-2015
  • Fecha de inicio del evento
    2014-10-16
  • Fecha de publicación del evento
    2015-09-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130895
  • 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
    Factor b, antigen, antiserum, control - Product Code JZH
  • Causa
    Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
  • Acción
    Quidel sent an Urgent Medical Device Recall letter dated October 16, 2014, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review their inventory and determine if they have of the affected product. If so, they should remove it from their inventory and destroy it immediately by discarding it into their normal biomedical waste stream. Complete the enclosed Certificate of Destruction. Upon receipt of the Certificate of Destruction, Quidel, will then schedule their shipment of replacement product. If consignees further distributed the affected product, they should identify the customers and provide them with the Urgent Medical Device Recall. Consignees were instructed to monitor and reconcile the quarantine of product with the customers as this information may need to be provided to the authorities. For questions regarding this recall call 740-589-3300. For technical support consignees should contact technicalsupport@quidel.com or call 800-874-1517.

Device

MicroVue Bb Plus EIA
  • Modelo / Serial
    Model Number A027; Lot Number 018186;  (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.
  • Descripción del producto
    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
  • Manufacturer
    Diagnostic Hybrids Inc

Manufacturer

Diagnostic Hybrids Inc
  • Dirección del fabricante
    Diagnostic Hybrids Inc, 1055 E State St, Suite 100, Athens OH 45701-7911
  • Empresa matriz del fabricante (2017)
    Quidel Corporation
  • Source
    USFDA