AIA-900 Automated Immunoassay Analyzer — Class II medical device recall Z-0509-2019
Terminated recall by Tosoh Bioscience Inc, reported 2018-12-05, distributed nationwide. Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive moto
| Recall number | Z-0509-2019 |
|---|---|
| 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 | 2018-11-28 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2020-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, DO, EC, GT, HN, KY, PE, UY, VE |
| Quantity | 247 |
| Serial numbers | 10142204, 10212711, 10253102R, 10373208, 10403809, 10463110, 10493811, 10503612, 10513412, 10614102, 10634103, 10654404 |
Product
AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
Reason for recall
Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase the lateral load on the motor axis resulting in the inclination and damage of the motor axis. Since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. If the drive motor fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received five (5) 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-0509-2019. 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.