Device Recall Roche ACCUCHEK Softclix Lancing Device

  • 모델명 / 제조번호(시리얼번호)
    Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5. Model 3583031002; lots M25C9, M25D2, M27D6, M32A8 and M32B3.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 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
  • 1 Event

제조사

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