Events

Retiro De Equipo (Recall) de Device Recall CHROMagar

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 DRG International 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
    53841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1068-2010
  • Fecha de inicio del evento
    2009-11-09
  • Fecha de publicación del evento
    2010-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86650
  • 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
    Culture media, antimicrobal susceptibility test, excluding mueller hinton agar - Product Code JSO
  • Causa
    Chromagar products are labeled incorrectly. label currently states that the product is for ivd use, when it should state that the product is intended for research use, not for use in diagnostic procedures.
  • Acción
    Two recall letters were sent via certified mail to customers. One letter was dated November 9, 2009 referencing the CHROMagar VRE product and the other letter dated November 12, 2009 referencing the CHROMagar 0157 product. The letters describe the affected product, problem, and action to be taken by the customer. The customers are to please STOP the use or distribution of the listed products and IMMEDIATELY examine your stock and return any un-expired CHROMagar product slated for recall for replacement the DRG International, Inc. The customers are being requested to please fill out and return the disposition sheet even if you have none of these items on hand since the information is important. If you have any questions, please contact customer service at (908) 233-0758.

Device

Device Recall CHROMagar
  • Modelo / Serial
    Catalog numbers EE220, EE222, all lots within expiry.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution
  • Descripción del producto
    CHROMagar 0157; || 5000 ml (29.2 g/L) || EE222; IVD || For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. || Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.
  • Manufacturer
    DRG International Inc

Manufacturer

DRG International Inc
  • Dirección del fabricante
    DRG International Inc, 1167 US Highway 22, Mountainside NJ 07092-2807
  • Empresa matriz del fabricante (2017)
    Drg International Inc
  • Source
    USFDA