Tosoh Bioscience Inc recalls Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for th

Recalled May 23, 2018 · FDA recall Z-1809-2018 · Tosoh Bioscience

Hazard

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. · FDA Class II

Units

6049

Sold at

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.

Description

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

Product

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(s)

Tosoh Bioscience Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →