Events

Retiro De Equipo (Recall) de Microscan Neg/Urine Combo 61, B1017414

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 Beckman Coulter, 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
    70893
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1532-2015
  • Fecha de inicio del evento
    2014-08-08
  • Fecha de publicación del evento
    2015-04-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135437
  • 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
    Technical support bulletin issued in february 2013 did not mention performance limitation for proteus mirabilis and imp when using the clsim100-s20 revised interpretive criteria.
  • Acción
    The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated August 7, 2014 to affected customers by trackable method. The letter describe product, problem and actions to be taken. The customers were instructed to confirm receipt of the letter; complete the attached "Field Correction Effectiveness Check" form via fax to Siemens Healthcare Diagnostics at 302-631-8467;TSB 190 has been removed from use and archived from the Siemens Document Library, if you have a hardcopy, discard it appropriately;and follow the listed in instructions and retain and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center; Quality Systems & Compliance Director at 916-374-3031 or email: juntalan@beckman.com or your local Siemens technical support representative.

Device

Microscan Neg/Urine Combo 61, B1017414
  • Modelo / Serial
    Catalog number: B1017-414; Siemens Material Number (SMN):  10483097.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.
  • Descripción del producto
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels || Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 || Breakpoints || Panel: Neg/Urine Combo 61, Catalog B1017-414 || Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed || for use in determining antimicrobial agent susceptibility and/or identification to the || species level of aerobic and facultatively anaerobic gram-negative bacilli.
  • Manufacturer
    Beckman Coulter, Inc.

Manufacturer

Beckman Coulter, Inc.
  • Dirección del fabricante
    Beckman Coulter, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA