Events

Retiro De Equipo (Recall) de Device Recall Pacific Hemostasis FDP Latex Reagent

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 Fisher Diagnostics.

¿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
    77340
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2763-2017
  • Fecha de inicio del evento
    2017-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155790
  • 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
    System, fibrinogen determination - Product Code KQJ
  • Causa
    An issue was discovered with the pacific hemostasis fibrinogen degradation products (fdp) kit, list number 100650, lot 948546 and fdp latex reagent, list 100651, lot 890199. while the kit performs accurately at fdp concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when fdp levels are less than 20 ¿g/ml. this reduction in sensitivity has been tied to fdp latex reagent lot 890199 and may result in false negatives.
  • Acción
    ThermoFisher Scientific sent an MEDICAL DEVICE RECALL Letter dated May 16, 2017, to all affected customers and response forms were sent to customers on May 19, 2017. Customers are informed of the recall and potential health risks and instructed to review their test results. Review your inventory and any product on hand is to be discarded. --- The firm ceased distribution of the lots and began its investigation. The held product will ultimately be destroyed. Level A effectiveness checks will be conducted to the consignees and repeated attempts will be made to non-responding customers. The firm will track all mailed, emailed and faxed return forms for the duration of the recall. For further questions, please call (540) 869-8188.

Device

Device Recall Pacific Hemostasis FDP Latex Reagent
  • Modelo / Serial
    Lot Number 890199, Exp. 6/30/2018
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) including Puerto Rico, and Internationally to Colombia
  • Descripción del producto
    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
  • Manufacturer
    Fisher Diagnostics

Manufacturer

Fisher Diagnostics
  • Dirección del fabricante
    Fisher Diagnostics, 8365 Valley Pike, Middletown VA 22645-1905
  • Source
    USFDA