Device Recall Alk Phos R2

  • 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
    Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos. 7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90, 8-A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. 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