FDA Device recall Z-0469-2019
AIA-900 Analyzer, Product code 022930, 022930R
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of AIA-900 Analyzer, Product code 022930, 022930R by Tosoh Bioscience, citing 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 an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0469-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-05 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
Product
AIA-900 Analyzer, Product code 022930, 022930R
Reason
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.
Identifiers
| code_info | All units are affected |
|---|
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-0469-2019%22
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