Events

Retiro De Equipo (Recall) de Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II 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 Becton Dickinson & Co..

¿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
    69091
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0974-2015
  • Fecha de inicio del evento
    2014-06-06
  • Fecha de publicación del evento
    2015-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129613
  • 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, selective and differential - Product Code JSI
  • Causa
    A low level of surface and subsurface contamination of listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. the contamination is typically observed as 1-3 cfus per plate when present.
  • Acción
    BD Diagnostic Systems sent a Field Correction Notice dated August 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to follow all surveillance requirements of their laboratory upon confirmation of Listeria monocytogenes. Laboratory staff should notify their respective state health department. Customers with questions should contact BD Technical Services at 800-638-8663. For questions regarding this recall call 410-316-4000.

Device

Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar
  • Modelo / Serial
    Catalogue # 221291 with Lot #4050354,  4086399,  4099206 and 4143653; Catalogue #221261 with Lot # 4022158 4086443 4092199
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
  • Descripción del producto
    TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar || Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Dirección del fabricante
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA