Device Recall Pointe Scientific Liquid Glucose HEX

Manufacturer

  • Manufacturer Address
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lots 511901, exp. 4/07 and 525101, exp. 9/07.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.
  • Product Description
    Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog number HG420-R2.
  • Manufacturer
  • Model / Serial
    Lots 431704, exp. 11/06 and 511901, exp. 4/07.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.
  • Product Description
    Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent, or 1 x 2 L R1 x 500 ml R2, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers HG920-1200 and HG920-2500.
  • Manufacturer
  • Model / Serial
    Lots 431704, 511901 and 525101.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.
  • Product Description
    Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300.
  • Manufacturer