FDAFDA · Alimentos y medicamentos·N.º oficial Z-1843-2014
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.
Publicado el 2 de julio de 2014 · Inicio del retiro: 27 de mayo de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- BioFire Diagnostics, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA.
- Lote
- 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 de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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