Retiro De Equipo (Recall) de Device Recall MacConkey Agar with Ciprofloxacin

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 macconkey agar with ciprofloxacin, brain heart infusion broth with ciprofloxacin 1 ug, mdr acinetobacter, bea with azide and vancomycin, bea agar with vancomycin, gentamicin, and amphotericin b, bea broth with vancomycin, and vre broth 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 discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the endlosed form stating their compliance with the above action. The notification states if the laboratory was unable to be reached via telephone and would like a credit to contact the Customer Service Department at 800-266-2222, option 1. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at Follow-up calls will be made to customers who do not respond.


  • Modelo / Serial
    Lot number: 15096 and 15107
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    U.S. Nationwide Distribution and the country of: Canada
  • Descripción del producto
    Hardy Diagnostics || MacConkey Agar with CiPRP, 1ug/ml || Container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.
  • Manufacturer


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