FDA-Device2018-05-23Class II
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.
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
2864
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2018More Tosoh Bioscience Inc recalls
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