Device recall
Z-0607-2009: Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the…
FDA device recall · Class II · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-0607-2009 |
|---|---|
| Recall event | 50162 |
| Product | Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of… |
| Product code | LJB |
| Recalling firm | Diamedix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2010 |
| 510(k) numbers | K974552 |
| 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