Events

Retiro De Equipo (Recall) de Device Recall HardyCHROM VRE Agar

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 Hardy Diagnostics.

¿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
    71577
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2192-2015
  • Fecha de inicio del evento
    2015-06-24
  • Fecha de publicación del evento
    2015-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138251
  • 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, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
  • Causa
    Hardy diagnostics is recalling hardychrom vre agar due to lack of 510(k) clearance.
  • Acción
    The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com.

Device

Device Recall HardyCHROM VRE Agar
  • Modelo / Serial
    Cat No.: G333 Lot No.: H15055
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to one U.S. customer in SC.
  • Descripción del producto
    HardyCHROM VRE Agar-RSR || Cat no: GA333 Lot no: H15055 || Expires: 2015-07-04 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage 2 to 8 degrees C on receipt || Chromogenic medium for stool pathogen screening.
  • Manufacturer
    Hardy Diagnostics

Manufacturer

Hardy Diagnostics
  • Dirección del fabricante
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Empresa matriz del fabricante (2017)
    Hardy Diagnostics
  • Source
    USFDA