G8 Automated HPLC Analyzer — Class II medical device recall Z-3244-2018
Terminated recall by Tosoh Bioscience Inc, reported 2018-10-03, distributed nationwide. Analyzers were distributed with software which lacks a 510K
| Recall number | Z-3244-2018 |
|---|---|
| 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 | 2018-07-13 |
| Classified | 2018-09-25 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2020-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| Reason classes | software |
| Serial numbers | 14616503, 14646304, 14856212, 14886112, 14886212, 14887601, 14917201 |
Product
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Reason for recall
Analyzers were distributed with software which lacks a 510K
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-3244-2018. 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.