FDAFDA · Alimentos y medicamentos·N.º oficial Z-2236-2014
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Publicado el 20 de agosto de 2014 · Inicio del retiro: 9 de julio 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
Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Nanosphere, Inc.
- Distribuidor
- Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
- Lote
- VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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