Events

Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measurement.

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 Clinical Diagnostic Systems.

¿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
    79508
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1322-2018
  • Fecha de inicio del evento
    2018-01-11
  • Fecha de publicación del evento
    2018-04-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162526
  • 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
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Causa
    Vitros tsh reagent lots have been found to generate higher than expected calibrator level 2 signals on some customer systems. these calibrator level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the customer calibration curve between calibrator level 2 and calibrator level 3.
  • Acción
    Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.

Device

Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack for in vitro quantitative measu...
  • Modelo / Serial
    Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
  • Descripción del producto
    VITROS Immunodiagnostic Products TSH Reagent Pack
  • Manufacturer
    Clinical Diagnostic Systems

Manufacturer

Clinical Diagnostic Systems
  • Dirección del fabricante
    Clinical Diagnostic Systems, 601 Lee Rd Ny, Rochester NY 14652-0001
  • Empresa matriz del fabricante (2017)
    Boule Diagnostics AB
  • Source
    USFDA