Device Recall Roche ACCUChek Voicemate Meter

  • Model / Serial
    REF 12030802001; lot 550594A. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 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
  • 1 Event

Manufacturer

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