Devices

Device Recall Roche Coaguchex XS Systems for Patient SelfTesting

  • Model / Serial
    REF 04837738001; 117200, 117202, 117203, 117204, 117205, 117208, 117209, 117213, 117216, 117219, 117220, 117222, 117227, 117228, 117229, 117231, 117233, 117235, 117237, 117238, 117240 and 117241. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 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

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA