AIA-360 Analyzer is capable of performing two methods of immunoassay:… — Class II medical device recall Z-0613-2019
Terminated recall by Tosoh Bioscience Inc, reported 2018-12-26, distributed nationwide. The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sen
| Recall number | Z-0613-2019 |
|---|---|
| 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 | 2017-03-22 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-12-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CO, CR, EC, HN, MX, PA, UY, VE |
| Quantity | 438 |
| Reason classes | device malfunction |
Product
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) 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
The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 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 three (3) 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-0613-2019. 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.