FDAFDA · Alimentos y medicamentos·N.º oficial Z-3180-2018
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
Publicado el 26 de septiembre de 2018 · Inicio del retiro: 13 de agosto de 2018
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
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- bioMerieux, Inc.
- Distribuidor
- Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,
- Lote
- Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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