Device recall
Z-1045-2009: RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test…
FDA device recall · Class III · Immuno Concepts Inc
Key facts
| Recall number (Z-number) | Z-1045-2009 |
|---|---|
| Recall event | 50519 |
| Product | RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA. |
| Product code | LLL |
| Recalling firm | Immuno Concepts Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 17, 2009 |
| 510(k) numbers | K935129 |
| FEI number | 2918768 |
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