Tosoh Bioscience, Inc. recalls Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
See all recalls from Tosoh Bioscience, Inc. →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
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Tosoh Bioscience HLC-723G8 Analyzer →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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