AIA-900 Analyzer — Class II medical device recall Z-2423-2020
Terminated recall by Tosoh Bioscience Inc, reported 2020-07-01, distributed nationwide. The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue ma
| Recall number | Z-2423-2020 |
|---|---|
| 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 | 2020-05-22 |
| Classified | 2020-06-23 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2024-08-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, CR, DO, EC, GT, HN, KY, PA, PE, SV, UY |
| Quantity | 529 |
| UPC / GTIN / UDI-DI | 04560189283992 |
| Serial numbers | 10030810, 10101008, 10142204, 10212411, 10253902, 10263902 |
| Model numbers | 022930 |
Product
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Reason for recall
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
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-2423-2020. 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.