Device Recall BD Viper LT System

  • Modèle / numéro de série
    Only the BD Viper LT Systems, catalog number 442839, that utilize the CT/GC Assays are affected. Serial numbers VLT0040, VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, VLT0033.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
  • Description du dispositif
    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Société-mère du fabricant (2017)
  • Source
    USFDA