Device Recall Alkaline Phosphatase Substrate

  • Modèle / numéro de série
    Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela.
  • Description du dispositif
    Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro diagnostic.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Société-mère du fabricant (2017)
  • Source
    USFDA