Devices

Device Recall ST AIAPACK PROG II

Manufacturer

Tosoh Bioscience Inc
  • Manufacturer Address
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Manufacturer Parent Company (2017)
    Tosoh Corp.
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall ST AIAPACK PROG III Calibrator Set
  • Model / Serial
    Catalog Number 02534001 (One set of Calibrators US)  Lot G13C303 (only those received/repackaged in the US)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
  • Product Description
    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.
Device Recall ST AIAPACK PROG III
  • Model / Serial
    All lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
  • Product Description
    ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240
  • Manufacturer
    Tosoh Bioscience Inc