Device recall
Z-1620-2012: Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme…
FDA device recall · Class II · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-1620-2012 |
|---|---|
| Recall event | 61568 |
| Product | Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying… |
| Product code | LLL |
| Recalling firm | Diamedix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2013 |
| 510(k) numbers | K980759 |
| 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