Events

Retiro De Equipo (Recall) de Device Recall SimpliRED Ddimer Assay

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 BBI SOLUTIONS OEM LTD.

¿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
    74786
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0314-2017
  • Fecha de inicio del evento
    2016-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148459
  • 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
    Fibrin split products - Product Code GHH
  • Causa
    A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. qualitative results may be affected. false negative results are possible which may incorrectly influence the clinical diagnostic decision.
  • Acción
    BBI Solutions sent an Urgent Medical Device Recall letter dated June 30, 2016, to all affected customers. Customers were advised to immediately discontinue use of the product, consider the requirement for review of reported test results, complete and return the customer acknowledgement form to BBI Solutions and to complete and return the customer reconciliation form to the distributor. Customers who have forwarded product to other sites, should inform those customers of the product recall and provide them with a copy of the notice. Customers with questions were instructed to call Tel: +44(0)1382 564093.

Device

Device Recall SimpliRED Ddimer Assay
  • Modelo / Serial
    Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US distribution to CT and IN
  • Descripción del producto
    SimpliRED D-Dimer, Product Code DSRK4 || The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
  • Manufacturer
    BBI SOLUTIONS OEM LTD

Manufacturer

BBI SOLUTIONS OEM LTD
  • Dirección del fabricante
    BBI SOLUTIONS OEM LTD, 8 Tom McDonald Avenue, Dundee United Kingdom
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA