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

Recall date

November 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1225-2017

FDA classification

Class II

Brand / firm

Tosoh Bioscience, Inc.

Sold / distributed

Worldwide distribution. The products were shipped to the following 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, AND WY. The recalled products were sh…

Why it was recalled

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%.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.