Device Recall Bayer Contour TS blood glucose test strips

  • 모델명 / 제조번호(시리얼번호)
    Test strip lots WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C, WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A, WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F, WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C, WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C, WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A, WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.
  • 제품 설명
    Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; Bayer Healthcare, Mishawaka, IN. U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bayer Healthcare LLC, 430 S Beiger Street, Mishawaka IN 46544-3207
  • Source
    USFDA