Events

Retiro De Equipo (Recall) de Device Recall Roche cobas

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
    63310
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0188-2013
  • Fecha de inicio del evento
    2012-07-31
  • Fecha de publicación del evento
    2012-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113477
  • 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
    Somatic gene mutation detection system - Product Code OWD
  • Causa
    It was identified that braf controls dispositioned as "internal use only" were incorrectly packaged into cobas 4800 braf v600 mutation test ce-ivd kit lot r03607 and released for distribution. two control batches manufactured during two process validation studies are involved: pv7711: braf mutant (mut) control pv0853: braf wild type (wt) control.
  • Acción
    Roche sent a Safety Board Notice - Product Bulletin 2012-013 on 31-Jul-2012 to affected customers. The notice identifed the affected product, description of situation and actios to be taken. Customers were instructed to discontinue use, quarantine and discard any remaining kits of the affected product in inventory. Customers were advised to contact their affiliate sales office for replacement. The notice states a new cobas 4800 BRAF V600 Mutation Test lot (R07749) is anticipated to be available on 03-Aug-2012. For questions call +01.908.253.7569.

Device

Device Recall Roche cobas
  • Modelo / Serial
    Material number 05985595190; Lot number R03607
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
  • Descripción del producto
    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., || Product Usage: || The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
  • 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