Events

Retiro De Equipo (Recall) de Device Recall DRI Salicylate Serum Tox Assay

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 Microgenics Corporation.

¿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
    74861
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2884-2016
  • Fecha de inicio del evento
    2016-07-25
  • Fecha de publicación del evento
    2016-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148620
  • 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
    Colorimetry, salicylate - Product Code DKJ
  • Causa
    Some lots of dri salicylate serum tox assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dl.
  • Acción
    The firm, Thermo Fisher Scientific, sent an "URGENT MEDICAL DEVICE FIELD ACTION" letter dated July 25, 2016 by regular mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to determine if they are using or have inventory of any of the affected lots; discontinue use and destroy any remaining inventory of affected lots per local wastes ordinances; retain a copy of the letter for laboratory records; if you have forwarded kits of the affected lots, provide a copy of letter to them; and complete and return attached Medical Device Field Action Response Form within 5 days to Thermo Fisher Scientific Technical Service via fax at 1-888-527-8001 (USA toll free), 510-979-5420 (outside of USA) or email to techservice.mgc@thermofisher.com. If you have any questions contact Technical Services at 1-800-232-3342 (USA only) or 510-969-5000 (outside the USA) press option 2 then option 3.

Device

Device Recall DRI Salicylate Serum Tox Assay
  • Modelo / Serial
    Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
  • Descripción del producto
    DRI Salicylate Serum Tox Assay, Catalog number 0977. || Toxicology: || The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Dirección del fabricante
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA