Device Recall Tosoh ST AIAPACK HbA1c Control

  • Modèle / numéro de série
    All lots.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Description du dispositif
    Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 || The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Société-mère du fabricant (2017)
  • Source
    USFDA