Events

Retiro De Equipo (Recall) de Device Recall HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT

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 International Technidyne 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
    52018
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1732-2009
  • Fecha de inicio del evento
    2009-05-05
  • Fecha de publicación del evento
    2009-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81917
  • 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
    Activated whole blood clotting time - Product Code JBP
  • Causa
    One lot of act-lr was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
  • Acción
    An "Urgent - Medical Device Recall" letter dated May 4, 2009 was sent to healthcare professionals. The recall letter described the reason for recall and the possible health risks involved. Consignees were asked to check their inventory for the affected lot number and return the completed Customer Account Tracking form via mail, e-mail or fax to ITC. ITC will make arrangements for the return of affected product. If there is no affected product in the inventory and no product or safety concerns, the letter is for information purposed only. Note: the Customer Account Tracking form should be completed in all cases. If you have questions regarding the recall information, please call ITC Technical Support at 1-800-579-2255, or email ITC at JACTLR@itcmed.com.

Device

Device Recall HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
  • Modelo / Serial
    Lot number K8JLR118.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Hemochron Jr. ACT- LR Assay (JACT- LR); || ITC Catalogue/Code Number: JACTLR || 45 Cuvettes; || For Performance on the HEMOCHROM Whole Blood Microagulation Systems; || International Technidyne Corp., Edison, NJ 08820. || The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Dirección del fabricante
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA