Events

Retiro De Equipo (Recall) de Device Recall PerkinElmer Specimen Gate Screening 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 PerkinElmer Life and Analytical Sciences, Wallac, OY.

¿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
    79421
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1541-2018
  • Fecha de inicio del evento
    2017-11-17
  • 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=162274
  • 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
    Potential errors in patient results generated by the screening center product that include both false negative and false positive results.
  • Acción
    PerkinElmer sent an Urgent Medical Device Correction letter dated November 14,2017. Instructions: 1. Implement additional control measures concerning demographic information, by taking one of the following actions a. Fully enter demographics before loading specimens on instruments (i.e. specimens can be punched, but the assay plates cannot be loaded to the measurement instruments). b. If the above mentioned is not possible or if previously entered demographic information changes after loading the assay plates on the measurement instruments, recalculate all your results in Specimen Gate laboratory Result Viewer prior to assay acceptance. 2. Follow unreported specimens with available tools to avoid any delay in reporting screening results. For further questions, please call (317) 418-1735

Device

Device Recall PerkinElmer Specimen Gate Screening Center
  • Modelo / Serial
    All software versions from 1.0 to 1.8 (current software version)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
  • Descripción del producto
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) || Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
  • Manufacturer
    PerkinElmer Life and Analytical Sciences, Wallac, OY

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY
  • Dirección del fabricante
    PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    USFDA