Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing — Class II medical device recall Z-1225-2017
Terminated recall by Tosoh Bioscience, Inc., reported 2017-03-01, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. The device defect associated with this recall may result in HbA1c values with a negative bias in patients with
| Recall number | Z-1225-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience, Inc., South San Francisco, CA, United States |
| Recall initiated | 2016-11-07 |
| Classified | 2017-02-17 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2021-02-09 |
| Distributed | 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 |
| Countries outside the US | BR, CL, CR, DO, GT, NI, PA, PE, UY |
| Quantity | 682 analyzers |
Product
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Reason for recall
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%.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1225-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.