Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. Recalled by Tosoh Bioscience, Inc. Due to The device defect associated with this recall may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience, Inc. directly.
Affected Products
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Quantity: 682 analyzers
Why Was This 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%.
Where Was This Sold?
This product was distributed to 48 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY
About Tosoh Bioscience, Inc.
Tosoh Bioscience, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report