Class II — Tosoh Bioscience Inc
| Recalling firm | TOSOH BIOSCIENCE |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. |
| Product | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay. |
| Quantity | 1485 |
| Distribution | USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. |
| Initiated | 2018-03-05 |
| Classified | 2018-05-14 |
| Terminated | 2020-06-16 |
| Recall number | Z-1810-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Tosoh Bioscience Inc (Z-1810-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79708/
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