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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1524-2017

Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Publicado el 29 de marzo de 2017 · Inicio del retiro: 15 de diciembre de 2016

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

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
BioMerieux SA
Distribuidor
Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia
Lote
Reference no. 508650, Lot #1001060450, 1001154650, 1001212890, 1001264540, 1001319180, 1001390080, 1001390440, 1001409510, 1001409520, 1001441760, 1001540660, 1001589490, 1001621240 & 1001656460; Reference no. 508658, Lot #1001093880, 1001154820, 1001265110, 1001319480, 1001390570, 1001441910, 1001487610, 1001647880, 1001708510, 1001811360, 1002041010, 1002102920, 1002435570, 1002567240, 1002725010, 1003246020, 1003889730, 1004168400, 1004364330, 1004491220 & 1004939670; Reference no. 508610, Lot #1001026950, 1001199360 1001427690, 1001518090, 1001595490, 1001740320 & 1001989260 and Reference no. 508618, Lot #1001032350, 1001242030, 1001338050, 1001416820, 1001471720, 1001595500, 1001627650, 1001720440, 1001728140, 1001786480, 1001956220, 1002109250, 1002338880, 1002435190, 1002566960, 1002718380, 1002975330, 1003886270, 1003894060, 1003981160, 1004064990, 1004075190, 1004168390, 1004490810 & 1004939640.
Clasificación de riesgo
Class II
Área (FDA)
device
País
France

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