FDA Device recall Z-1225-2017
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing
- FDA Device
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing by Tosoh Bioscience, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1225-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-07 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Reason
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%.
Identifiers
| code_info | All active analyzers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1225-2017%22
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