Events

Retiro De Equipo (Recall) de VITROS CKMB Calibrators

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 Ortho-Clinical Diagnostics.

¿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
    64901
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1337-2013
  • Fecha de inicio del evento
    2013-04-03
  • Fecha de publicación del evento
    2013-05-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117358
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Causa
    Internal testing demonstrated that opened-reconstituted vitros ck-mb calibrators stored at -20 degrees celsius (-4 degrees farenheit) generated invalid calibrations that were detected by positively biased quality control results.
  • Acción
    Ortho Clinical Diagnostic sent a " Important Product Correction Notification" letter dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed of the issue and advised they must discontinue storage of opened-reconstituted vials of VITROS CK-MB Calibrators frozen at -20 degrees Celsius (-4 degrees Farenheit). The same day, the Distributor letters were sent via US Postal Service Priority Mail or FedEx overnight courier to US Distributor consignees who were informed of the issue and instructed to notify their customers of the issue and actions. Also on April 3, 2013, the foreign affiliates were informed of the issue by e-mail and instructed to notify their consignees of the issue and actions. Confirmation of Receipt - Important Response Required so that we can complete our records, please return this form to us no later than April 19, 2013. FAX: 1-888-557-3759 or 1-585-453-4110 We apologize for any inconvenience this may have caused your laboratory. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.

Device

VITROS CKMB Calibrators
  • Modelo / Serial
    Lots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Descripción del producto
    VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK || For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
    The Carlyle Group LP
  • Source
    USFDA