FDA-Device2018-05-23Class II
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.
Tosoh Bioscience Inc
Hazard
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Sold states
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.
Affected count
1485
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2018Don't want to check this manually?
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