Events

Retiro De Equipo (Recall) de Device Recall MagNA Pure 24 System Pathogen Protocols

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 Roche Molecular Systems, Inc..

¿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
    79899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1956-2018
  • Fecha de inicio del evento
    2018-05-02
  • 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=163850
  • 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
    Clinical sample concentrator - Product Code JJH
  • Causa
    Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
  • Acción
    Customers were notified of the field action by letter on 4/27/18. The letter included the following required actions: " If you used the MagNA Pure 24 Pathogen 200 and/or Pathogen 1000 protocols to extract nucleic acids for an assay for a chronic infectious disease (e.g., Hepatitis C Virus), then suspected false positives should be evaluated further following local procedures and retested as necessary. " Complete the attached fax form and fax it to 1-844-861-6232 or email it to roche6612@stericycle.com. " File this Urgent Medical Device Correction (UMDC) for future reference.

Device

Device Recall MagNA Pure 24 System Pathogen Protocols
  • Modelo / Serial
    Device Identifier: 07613336106174
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.
  • Descripción del producto
    MagNA Pure 24 System, GMMI: 07290519001 || Product Usage: || The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Dirección del fabricante
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA