Devices

Device Recall Roche ACCUChek Active Meter Kit

  • Model / Serial
    REF 03184501001; lots 116099, 116109, 116122, 116135, 116145, 116146, 116155, 116167, 116185, 116190, 116192, 116205, 116209, 116215, 116229, 116230 and 116237. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 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