Tosoh AIA-900 immunoassay Analyzer — Class II medical device recall Z-0485-2019
Terminated recall by Tosoh Bioscience Inc, reported 2018-11-28, distributed in GA, NY. A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritt
| Recall number | Z-0485-2019 |
|---|---|
| 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 | 2018-09-28 |
| Classified | 2018-11-19 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2020-07-08 |
| Distributed | GA, NY |
| Quantity | 3 |
| Reason classes | software |
Product
Tosoh AIA-900 immunoassay Analyzer
Reason for recall
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
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-0485-2019. 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.