Device Recall Bayer Contour TS blood glucose test strips

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.
  • Product Description
    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

Manufacturer

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