Events

Retiro De Equipo (Recall) de Device Recall QuickSlide MGS80 MutliSlide Gram Stainer/GramPRO80

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
    74356
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2146-2016
  • Fecha de inicio del evento
    2016-05-24
  • Fecha de publicación del evento
    2016-07-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147263
  • 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
    Slide stainer, automated - Product Code KPA
  • Causa
    Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
  • Acción
    The firm began notifying consignees via phone on 05/23/16. The firm also sent out Urgent Notification letters, dated June 15, 2016. The firm's phone script instructs customers to decrease the number of rinses on the slide and increasing the number of rinses in the chamber for better outcomes and performance with the instrument. Reducing the rinses on the slide may prevent bacteria from coming off the slide, and adding rinses to the empty chamber will help ensure that the chamber is clean before the next slide is introduced. The firm's customer notification letter recommended an immediate update to the automated rinse cycle to decrease the number of slide rinses and increase the number of empty chamber rinses to improve instrument performance. A step-by-step procedure for updating the rinse cycle settings was discussed via phone and should now be implemented. In addition to the changes, the firm is updating the GramPro 80 User Manual to reflect new recommendations, and it is strongly recommended that all users perform methanol fixation of slides for automated staining and discontinue the use of heat fixation to prevent cross contamination of the unit. Once updates to the User Manual have been completed, the firm will provide an updated revision for customer records. For further information or technical assistance, contact QuickSlide Technical Team at gibbsd@HardyDiagnostics.com.

Device

Device Recall QuickSlide MGS80 MutliSlide Gram Stainer/GramPRO80
  • Modelo / Serial
    All units manufactured between October 2014 and May 2016.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
  • Descripción del producto
    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. || Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
  • 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