Device recall
Z-1684-2008: Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with…
FDA device recall · Class II · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-1684-2008 |
|---|---|
| Recall event | 47430 |
| Product | Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect… |
| Product code | MST |
| Recalling firm | Diamedix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2009 |
| 510(k) numbers | K012795 |
| FEI number | 1044713 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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