Events

Retiro De Equipo (Recall) de Device Recall NeoBase Succinylacetone Assay Solution

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
    79303
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1692-2018
  • Fecha de inicio del evento
    2017-11-02
  • 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=161848
  • 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
    System, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry - Product Code NQL
  • Causa
    There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
  • Acción
    Actions to be taken: - Inspect your inventory of the NeoBase Succinylacetone Assay Solution vials for the affected lots. - If you notice leakage or deformed stopper seals, destroy the affected vials according to local instructions and regulations. - Complete the Response Form with the quantity and identity of affected Succinylacetone Assay Solution vials in your inventory. - Return the Response Form to PerkinElmer. - PerkinElmer will replace the quantity of leaking Succinylacetone Assay Solution vials found and destroyed from your inventory

Device

Device Recall NeoBase Succinylacetone Assay Solution
  • Modelo / Serial
    Affected lots: 654184 653414 653657 654923 655680 655300 654924 656025 657055 656170 656320 657768 657513 658006
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.
  • Descripción del producto
    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 || (01)06438147295708(17)180531(10)653414 || (01)06438147295708(17)180531(10)653657 || (01)06438147295708(17)180630(10)654923 || (01)06438147295708(17)180630(10)655680 || (01)06438147295708(17)180630(10)655300 || (01)06438147295708(17)180630(10)654924 || (01)06438147295708(17)180831(10)656025 || (01)06438147295708(17)180831(10)657055 || (01)06438147295708(17)180831(10)656170 || (01)06438147295708(17)180831(10)656320 || (01)06438147295708(17)181031(10)657768 || (01)06438147295708(17)181031(10)657513 || (01)06438147295708(17)181031(10)658006
  • 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