Device Recall FlowCount Fluorospheres

  • Modèle / numéro de série
    Part Number 7547053, Lot Number 754801F
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada. ***CENTER COMMENTS -- The Center requests that the subject recall not be terminated until CDRH has determined that the firm has identified the root cause and performed an adequate CAPA to address the cause of the problem, i.e., quality control.***
  • Description du dispositif
    Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA