FDAFDA · Alimentos y medicamentos·N.º oficial Z-0571-2016
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.
Publicado el 6 de enero de 2016 · Inicio del retiro: 3 de diciembre de 2015
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
Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Becton Dickinson & Company
- Distribuidor
- Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
- Lote
- Catalog Reference #367844; Lot number 5154624 Catalog Reference #367862; Lot numbers 5089771 and 5187753 Catalog Reference #368021; Lot number 5089820
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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