Device recall
Z-0509-2019: AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product…
FDA device recall · Class II · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-0509-2019 |
|---|---|
| Recall event | 81212 |
| 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… |
| Product code | KHO |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2020 |
| FEI number | 3005529799 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database