AIA-900 Analyzer — Class II medical device recall Z-0469-2019
Terminated recall by Tosoh Bioscience Inc, reported 2018-11-21, distributed nationwide. Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900
| Recall number | Z-0469-2019 |
|---|---|
| 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 | 2018-10-05 |
| Classified | 2018-11-14 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-11-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 393 |
| Reason classes | device malfunction |
Product
AIA-900 Analyzer, Product code 022930, 022930R
Reason for recall
Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) 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-0469-2019. 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.