Events

Retiro De Equipo (Recall) de IDSiSYS Intact PINP

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 Immunodiagnostics Systems Ltd.

¿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
    62968
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0044-2013
  • Fecha de inicio del evento
    2012-08-10
  • Fecha de publicación del evento
    2012-10-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112212
  • 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
    N/A - Product Code CIN
  • Causa
    It has been noted by staff at ids inc. that stock of the affected products held at ids inc. are labeled with ivd labels although they are not registered for sale as ivds in the united states. the products should have been labeled as research use only or investigational use only dependent on their usage.
  • Acción
    Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer: Customers should complete the attached Recall and Acknowledgement Form and take the following actions: 1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately. 2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return. 3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office. Contact information was also provided. For questions regarding this recall call +44 (191) 5195212.

Device

IDSiSYS Intact PINP
  • Modelo / Serial
    Lot 1170, EXP Feb 2013
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including NY, CA, ME and CT.
  • Descripción del producto
    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. || The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
  • Manufacturer
    Immunodiagnostics Systems Ltd

Manufacturer

Immunodiagnostics Systems Ltd
  • Dirección del fabricante
    Immunodiagnostics Systems Ltd, 10 Didcot Way Bolden Business Park, Boldon Tyne & Wear United Kingdom
  • Source
    USFDA