Events

Retiro De Equipo (Recall) de Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO

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
    62987
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0379-2013
  • Fecha de inicio del evento
    2012-08-20
  • Fecha de publicación del evento
    2012-11-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112207
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Causa
    In house testing confirmed that ck-ms and insulin claimed in both omni immune and omni immune pro products are displaying reduced stability.
  • Acción
    Microgenics Corporation sent a Recall Notification letter dated August 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed that immediate attention is required and identify the two affected constituents. The letter contains a list of the affected product with their catalog number, lot number and expiration date and request that the CK-MB and Insulin use be discontinued. The remaining components of the product may be used. Evaluate quality controls according to your laboratory procedures. Retain a copy of the letter for your laboratory records. If the product was forwarded to another laboratory, provide them with a copy of the letter. Complete the attached Recall Response form and return within 5 days. Questions may be directed to 1-800-232-3342.

Device

Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO
  • Modelo / Serial
    MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014.  MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
  • Descripción del producto
    Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; || Liquid Assayed Integrated Immunoassay Control. || Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. || .
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Dirección del fabricante
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA