Device recall
Z-0793-2013: OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by…
FDA device recall · Class III · Hitachi Chemical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0793-2013 |
|---|---|
| Recall event | 64132 |
| Product | OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France |
| Product code | DHB |
| Recalling firm | Hitachi Chemical Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 16, 2013 |
| 510(k) numbers | K051677 |
| FEI number | 2936856 |
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