Device Recall Tosoh ST AIAPACK HbA1c

  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 || The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
  • Manufacturer
  • 1 Event

Manufacturer

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

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 || The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
  • Manufacturer
  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
  • Model / Serial
    All lots.
  • Product Classification
  • 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.
  • Product Description
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 || The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
  • Manufacturer