FDA Device recall Z-0602-2019
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competi…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competi… by Tosoh Bioscience, citing the firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possib….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0602-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-28 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
Product
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
Reason
The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness 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 is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.
Identifiers
| code_info | All active analyzer serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0602-2019%22
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