Tosoh ST AIA-PACK HbA1c Pretreatment Solution — Class II medical device recall Z-1812-2018
Terminated recall by Tosoh Bioscience Inc, reported 2018-05-23, distributed nationwide. The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
| Recall number | Z-1812-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2018-03-05 |
| Classified | 2018-05-14 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2020-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,258 |
| Reason classes | potency |
Product
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Reason for recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
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-1812-2018. 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.