Events

Retiro De Equipo (Recall) de Device Recall AccuProbe MYCOBACTERIUM AVIUM COMPLEX IDENTIFICATION TEST

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 Gen-Probe 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
    55432
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1437-2011
  • Fecha de inicio del evento
    2008-12-30
  • Fecha de publicación del evento
    2011-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90839
  • 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
    Mycobacterium Spp. DNA-Reagents - Product Code LQF
  • Causa
    This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. the affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. possible false negative results.
  • Acción
    Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result. With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the amount destroyed on the Customer Response Form. Gen-Probe should be updated via phone, fax, and email information. Customers should then sign and return the completed form to Gen-Probe via fax to 858-410-8250, or scanned and emailed to technicalsupport@genprobe.com. The Technical Support team should be contacted for replacement kits. Technical Support was also available for additional information at 888-484-4747 or technicalsupport@gen-probe.com.

Device

Device Recall AccuProbe MYCOBACTERIUM AVIUM COMPLEX IDENTIFICATION TEST
  • Modelo / Serial
    Lots (batches): 555767
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
  • Descripción del producto
    Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.
  • Manufacturer
    Gen-Probe Inc

Manufacturer

Gen-Probe Inc
  • Dirección del fabricante
    Gen-Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
    Hologic, Inc.
  • Source
    USFDA