Events

Retiro De Equipo (Recall) de BacT/ALERT FA Reagent Bottle

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 bioMerieux, 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
    58550
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2244-2011
  • Fecha de inicio del evento
    2011-04-13
  • Fecha de publicación del evento
    2011-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99580
  • 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
    System, blood culturing - Product Code MDB
  • Causa
    The charcoal suspension in a portion of the lot does not meet the intended density.
  • Acción
    BioMerieux sent an Urgent Product Removal Notice dated April 13, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Evaluate positive results adhering to their institution's protocols for determining false versus true positives. Negative bottles should be checked by smear and/or subculture at some point prior to discarding as negative. Any remaining inventory of BacT/ALERT FA culture bottle lot 1027481 should be destroyed in accordance with their facility's policies and procedures. An Acknowledgement and Product Replacement Form was included to be completed and returned to bioMerieux or credit or replacement of unused bottles.

Device

BacT/ALERT FA Reagent Bottle
  • Modelo / Serial
    Catalog number: 259791, Lot umber 1027481, Expiry: December 8, 2011
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of China, Tokyo, South Korea, Canada, Sweden, Austria, Poland, and Belgium
  • Descripción del producto
    BacT/ALERT - FA Reagent Bottle || The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA bottle. BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacterial and fungi) from blood and other normally sterile body fluids.
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Dirección del fabricante
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA