AIA-360 Automated Immunoassay Analyzer — Class II medical device recall Z-1420-2020
Terminated recall by Tosoh Bioscience Inc, reported 2020-03-11, distributed in AZ, NE, NJ, NY, WA. A display screen software issue on the analyzer causes the display to freeze when display screen is touched at
| Recall number | Z-1420-2020 |
|---|---|
| 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 | 2020-01-10 |
| Classified | 2020-03-02 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2020-09-10 |
| Distributed | AZ, NE, NJ, NY, WA |
| Countries outside the US | CR, KY, UY |
| Quantity | 12 |
| Reason classes | software |
Product
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Reason for recall
A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.
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-1420-2020. 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.