Events

Retiro De Equipo (Recall) de Device Recall Etest CEFOTAXIME CT 256

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
    71475
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1947-2015
  • Fecha de inicio del evento
    2015-06-12
  • Fecha de publicación del evento
    2015-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137920
  • 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 results were out of range resulting in false resistant strains.
  • Acción
    BioMerieux sent an Urgent Product Removal Notices dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required actions: ¿¿ Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. ¿¿ Discontinue using and discard any remaining inventory of Etest¿¿ CEFOTAXIME CT 256 lots reported in table 1. ¿¿ Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. ¿¿ Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice and to request product replacement. bioM¿¿rieux is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused you. If you require additional assistance or have any questions, please contact your local bioM¿¿rieux Clinical Customer Service organization at (800) 682-2666.

Device

Device Recall Etest CEFOTAXIME CT 256
  • Modelo / Serial
    1002774320, 1002377890, 1002590470, 1002775330, 1002379610
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
  • Descripción del producto
    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
  • 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