Events

Retiro De Equipo (Recall) de Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit

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 Haemoscope Division of Haemonetics Corp.

¿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
    58847
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2742-2011
  • Fecha de inicio del evento
    2011-03-04
  • Fecha de publicación del evento
    2011-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100407
  • 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
    Hematology Multipurpose System for In Vitro Coagulation Studies - Product Code JPA
  • Causa
    Haemoscope received a report that during the process of validation, level ii qc was running with an out-of-range low ma (maximum amplitude).
  • Acción
    Haemoscope, a Division of Haemonetics Corp, sent a letter dated March 2, 2011 to all of the affected customers. The letters informed the customers that Haemoscope had received a higher than normal inquiry rate for the Level II Quality Control Kits, part 07-008, lots HMO196 and HMO 197. The accounts were requested to return their stocks of those two lots for further testing and evaluation and to complete the enclosed acknowledgement form, confirming receipt of the letter and the number of kit boxes being returned, and fax it back to Haemoscope at 847-588-0455. The returned kits will be replaced at no charge. For additional information please contact Haemoscope at 847-588-0453, ext-217 .

Device

Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit
  • Modelo / Serial
    part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
  • Descripción del producto
    TEG Hemostasis System Level II Control: || Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series || Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
  • Manufacturer
    Haemoscope Division of Haemonetics Corp

Manufacturer

Haemoscope Division of Haemonetics Corp
  • Dirección del fabricante
    Haemoscope Division of Haemonetics Corp, 6231 W Howard St, Niles IL 60714-3403
  • Empresa matriz del fabricante (2017)
    Haemonetics Corporation
  • Source
    USFDA