Devices

Device Recall ST AIAPACK PROG III

Fabricante

Tosoh Bioscience Inc
  • Dirección del fabricante
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Empresa matriz del fabricante (2017)
    Tosoh Corp.
  • Source
    USFDA

Dispositivo con un nombre similar

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Device Recall ST AIAPACK PROG III Calibrator Set
  • Modelo / Serial
    Catalog Number 02534001 (One set of Calibrators US)  Lot G13C303 (only those received/repackaged in the US)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
  • Descripción del producto
    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.