Device Recall BD Vacutainer Plus plastic whole Blood Collection Tubes

  • Modèle / numéro de série
    Catalog (Ref) # 367856; Lot Number 5014806
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.
  • Description du dispositif
    BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. || Product Usage: || 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. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Société-mère du fabricant (2017)
  • Source
    USFDA