Events

Retiro De Equipo (Recall) de Device Recall FilmArray Blood Culture Identification (BCID) Panel

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 BioFire Diagnostics, 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
    68352
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1843-2014
  • Fecha de inicio del evento
    2014-05-27
  • Fecha de publicación del evento
    2014-06-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127466
  • 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
    Gram-positive bacteria and their resistance markers - Product Code PAM
  • Causa
    Biofire has identified an increased risk of false positive results when the filmarray blood culture identification (bcid) panel is used with biom¿rieux bact/alert standard anaerobic (sn) blood culture bottles. false positive results have been observed for pseudomonas aeruginosa and enterococcus.
  • Acción
    BioFire Diagnostics sent an Urgent Recall/Correction letter on May 28, 2014. Customers were instructed If the BCID Panel is used to test BacT/ALERT SN bottles, positive results for Pseudomonas aeruginosa and Enterococcus should be confirmed by another method prior to reporting the test results. Customer with questions were instructed contact customer support at Support@biofiredx.com or via telephone by dialing 1-800-735-6544 and selecting option 5 for customer support and then option 1 for FilmArray. For questions regarding this recall call 801-736-6354, ext 360.

Device

Device Recall FilmArray Blood Culture Identification (BCID) Panel
  • Modelo / Serial
    426614,424514,424014,421114,419114,419214,417814,416214,416114,411214,411314,411014,410414,410014,408414,406314,404314,402314,403613,700113,698513,695313,692813,689813,689113,686313,685313,677713,668613,665013,667213,667113,663313,663013,665913,657313,659613,651413,647513,644613,632713,424614,424114,419514,419614,418014,416314,416414,412014,412114,411914,409914,406214,404414,700013,698413,695413,692913,689213,685413,668713,665113,667313,662913,657213,663913,660213,651513,647313,622213,
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA.
  • Descripción del producto
    FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 || The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, commonly encountered Staphylococci (including specific differentiation of Staphylococcus aureus), commonly encountered Streptococci (with specific differentiation of Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, commonly encountered Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis. The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA), vancomycin (vanA and vanB), and carbapenems (blaKPC) to aid in the identification of potentially antimicrobialresistant organisms in positive blood culture samples.
  • Manufacturer
    BioFire Diagnostics, Inc.

Manufacturer

BioFire Diagnostics, Inc.
  • Dirección del fabricante
    BioFire Diagnostics, Inc., 390 Wakara Way, Salt Lake City UT 84108-1214
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA