FDAFDA · Alimentos y medicamentos·N.º oficial Z-1570-2016
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
Publicado el 4 de mayo de 2016 · Inicio del retiro: 31 de marzo 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
One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Becton, Dickinson and Company, BD Biosciences
- Distribuidor
- Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.
- Lote
- Model: 340334; Manufacaturing lot: 534964
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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