ST AIA-PACK Testosterone — Class II medical device recall Z-0674-2019
Terminated recall by Tosoh Bioscience Inc, reported 2019-01-02, distributed nationwide.
| Recall number | Z-0674-2019 |
|---|---|
| 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 | 2018-11-30 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2021-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 26,745 units |
Product
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
Reason for recall
Not stated by FDA.
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-0674-2019. 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.