Events

Retiro De Equipo (Recall) de Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode

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 Tosoh Bioscience Inc.

¿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
    56584
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1075-2013
  • Fecha de inicio del evento
    2010-08-18
  • Fecha de publicación del evento
    2013-04-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94017
  • 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
    Hemoglobin a2 quantitation - Product Code JPD
  • Causa
    The beta-thalessemia mode of the g7 analyzer-beta thalassemia mode is an automated high performance liquid chromatography (hplc) system that separates and reports hbf and hba2 quantitative percentages in whole blood. the firm received complaints that the a2 peak could not be detected with the g7 beta-thalessemia columns.
  • Acción
    Please be aware that this is not a new recall. The firm has taken action. The firm stated that they have notified consignees via mail, with the list of notified customers maintained by the Regulatory Affairs/Quality Assurance department. The firm stated that they have notified distributors in the same way that they have notified other consignees, with a required confirmation to the firm of corrective actions.

Device

Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode
  • Modelo / Serial
    11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.
  • Descripción del producto
    G7 HPLC. || Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • Dirección del fabricante
    Tosoh Bioscience Inc, 3600 Gantz Road, Grove City OH 43123
  • Source
    USFDA