Device recall
Z-0218-05: TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12…
FDA device recall · Class I · Tosoh Bioscience, Inc.
Key facts
| Recall number (Z-number) | Z-0218-05 |
|---|---|
| Recall event | 30183 |
| Product | TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media |
| Product code | NIG |
| Recalling firm | Tosoh Bioscience, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 15, 2005 |
| 510(k) numbers | K971103 |
| FEI number | 1000123732 |
At a glance
- 1–9 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