Device recall
Z-0491-2018: TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930…
FDA device recall · Class II · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-0491-2018 |
|---|---|
| Recall event | 78776 |
| Product | TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series. |
| Product code | KHO |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2019 |
| 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