medical Class II Updated 2017-03-01

Tosoh Bioscience, Inc. recalls Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

Recalled Product

Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

Hazard / Issue

The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.

Issued by

FDA

Affected States: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Lot/Code Info: All active analyzers

View official government recall

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