Events

Retiro De Equipo (Recall) de Device Recall TEG Haemonetics System Level II Control

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 Haemonetics Corporation.

¿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
    70352
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1130-2015
  • Fecha de inicio del evento
    2015-01-26
  • Fecha de publicación del evento
    2015-02-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133242
  • 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, multipurpose for in vitro coagulation studies - Product Code JPA
  • Causa
    Specific lots of level ii control kits produce high maximum amplitude (ma) results, which are outside of the manufacturer's expected quality control range for ma parameter.
  • Acción
    Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.

Device

Device Recall TEG Haemonetics System Level II Control
  • Modelo / Serial
    Lot numbers: HMO 9200  HMO 9217  HMO 9226  HMO 9232  HMO 9276  HMO 9285  HMO 9292 Exp. Date 1/2017
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
  • Descripción del producto
    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. || Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Dirección del fabricante
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Empresa matriz del fabricante (2017)
    Haemonetics Corporation
  • Source
    USFDA