Events

Retiro De Equipo (Recall) de ETEST

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 SA.

¿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
    78688
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0265-2018
  • Fecha de inicio del evento
    2017-04-13
  • Fecha de publicación del evento
    2017-12-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160121
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Causa
    Qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest ox 256 (oxacillin) foam packaging (ref. 520558, 520518) reported. the product behavior could lead to false resistant results.
  • Acción
    BioMerieux sent an Urgent Field Safety Notice on April 30, 2017. Short-term Action: Subsidiaries and distributors are required to discard all ETEST¿ OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) under (PSS#3320) remaining in their inventory. In order to avoid any backorders on the field during the transition to the SPB configuration that is conformed to the expected specifications, Subsidiaries and Distributors were instructed to distribute the Urgent Field Safety Notice (customer letter) to inform Medical customers and Veterinary customers that have received and will receive the product. The Urgent Field Safety Notice informed customers of the non-conformity along with instructions to continue the use of the impacted products with recommendations described in customer letter, and in addition, for the Medical Customers, to discuss any concerns they may have regarding previously reported Susceptible results on the impacted batches Listed Table 1 with their Laboratory Medical Director to determine the appropriate course of action. Long-term Action: A CAPA (PR#1101306) has been initiated in order to identify the root-cause and prevent the issue to recur. They were instructed to complete and return the attached Acknowledgement Form by Fax to confirm receipt of this notice. For further questions, please call (314) 731-8694.

Device

ETEST
  • Modelo / Serial
    REF: 520518, Lot numbers: 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270 and 1005366110.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.
  • Descripción del producto
    ETEST OXACILLIN OX 256 WW F100 || In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
  • Manufacturer
    BioMerieux SA

Manufacturer

BioMerieux SA
  • Dirección del fabricante
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA