Devices

Device Recall Roche ACCUChek Aviva Meter Kit

  • Modèle / numéro de série
    REF 04893247001; lots 122136, 122137, 122143, 122155, 122179, 122187, 122196, 122198, 122213, 122224 and 122236. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). || The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event

Fabricant

Roche Diagnostics Corp.
  • Adresse du fabricant
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA