Events

Retiro De Equipo (Recall) de Device Recall Specimen Gate Screenig Center

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 Perkin Elmer Life Sciences 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
    72013
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0166-2016
  • Fecha de inicio del evento
    2015-08-24
  • 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=139579
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. the analytical test result value would be correct but the interpretation of the test result value would be incorrect.
  • Acción
    Perkin Elmer issued the Recall Letter on 8/24/15 delivered to the customer by email .Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures: Ensure all laboratory routine sample testing procedures are followed to avoid procedural anomalies. In the event a procedure anomaly occurs, review the final analytical result and the corresponding interpretation to confirm both are accurate before releasing the report. Once a PerkinElmer reporting error query is available, continue to run the query until the final corrective action is deployed to your site. The final corrective action will involve an installation update to the software. For further information, please contact your local PerkinElmer representative or specimen.gate.support@perkinelmer.com

Device

Device Recall Specimen Gate Screenig Center
  • Modelo / Serial
    Software Version 1.6
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US distribution to FL, GA, and NV; and Canada
  • Descripción del producto
    Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
  • Manufacturer
    Perkin Elmer Life Sciences Inc

Manufacturer

Perkin Elmer Life Sciences Inc
  • Dirección del fabricante
    Perkin Elmer Life Sciences Inc, Laitun 4 Mustionkatu 6, Turku Finland
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    USFDA