Device Recall AUTOHDL CHOLESTEROL REAGENT SET

  • Model / Serial
    Lot Number: 818202, exp. 12/09.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West Indies, Turkey and Venezuela.
  • Product Description
    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. || The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number: 810703, exp. 10/09.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West Indies, Turkey and Venezuela.
  • Product Description
    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. || The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
  • Manufacturer