FDA Device recall Z-0485-2019
Tosoh AIA-900 immunoassay Analyzer
- FDA Device
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of Tosoh AIA-900 immunoassay Analyzer by Tosoh Bioscience, citing A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released soft….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0485-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-28 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | GA, NY |
Product
Tosoh AIA-900 immunoassay Analyzer
Reason
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
Identifiers
| code_info | 10313605 10503612 10634103 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0485-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.