Events

Retiro De Equipo (Recall) de Device Recall Multigent Vancomycin 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 Microgenics Corp.

¿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
    60233
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0297-2012
  • Fecha de inicio del evento
    2011-06-08
  • Fecha de publicación del evento
    2011-11-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104837
  • 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
    Calibrators, drug specific - Product Code DLJ
  • Causa
    Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
  • Acción
    Microgenics sent a Product Removal notification letter dated June 15, 2011 to all affected customers. The letter identified the affected product, the problem, and the necessary actions to be taken. Customers were instructed to discontinue use and dispose of the affected product per local waste ordinances, review all patient results reported with the use of this lot, and retain a copy of this notification for their records. The letter states that if the affected product has been forwarded to another laboratory, a copy of the letter is to be provided to them. An alternative calibrator is available to customers impacted. It can be ordered by calling Thermo Fischer Scientific Customer Service at 1-800-232-3342. Questions regarding the information should be forwarded to Abbott Customer Service at 1-877-4ABBOTT.

Device

Device Recall Multigent Vancomycin Calibrators
  • Modelo / Serial
    Catalog number: 6E44-01; Lot 59446762, Exp 3/31/12; lot 59391741, Exp 12/31/2011.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) in the state of ILLINOIS
  • Descripción del producto
    Multigent Vancomycin Calibrators; || Manufactured by Microgenics Corp, Fremont, CA. || Distributed by: Abbott Diagnostics, Abbott Park, IL || Product Usage: || The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin || Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.
  • Manufacturer
    Microgenics Corp

Manufacturer

Microgenics Corp
  • Dirección del fabricante
    Microgenics Corp, 46360 Fremont Blvd, Fremont CA 94538
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA