Devices

Device Recall ST AIAPACK PROG III Calibrator Set

  • Modèle / numéro de série
    Catalog Number 02534001 (One set of Calibrators US)  Lot G13C303 (only those received/repackaged in the US)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
  • Description du dispositif
    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. || The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
  • Manufacturer
    Tosoh Bioscience, Inc.
  • 1 Event

Fabricant

Tosoh Bioscience, Inc.
  • Adresse du fabricant
    Tosoh Bioscience, Inc., 6000 Shoreline Ct Ste 101, South San Francisco CA 94080-7606
  • Société-mère du fabricant (2017)
    Tosoh Corp.
  • Source
    USFDA