Devices

Device Recall Roche ACCUChek Coaguchex XS Systems for Patient SelfTesting

  • Modèle / numéro de série
    REF 03149137001; lots 116137, 116148, 116151, 116157, 116180, 116194, 116199, 116216, 116224 and 116234. REF 05177294001; lots 116142, 116158 and 116204. REF 05079241001; lots 116134, 116141, 116149, 116164, 116170, 116171, 116188, 116191, 116202, 116207, 116212, 116217, 116221, 116231 and 116236. Lancet Model 3583031002; lots M25C9, M25D2, M27D6, M32A8 and M32B3.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3583031002 (17 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