Hemoglobin A1c Control — Class III medical device recall Z-0601-2019
Terminated recall by Tosoh Bioscience Inc, reported 2018-12-19, distributed nationwide. Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days prod
| Recall number | Z-0601-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2018-10-05 |
| Classified | 2018-12-13 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,000 |
| Reason classes | specification failure |
| Lot numbers | 7055 |
| Model numbers | 220232 |
Product
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Reason for recall
Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.
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-0601-2019. 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.