Device recall
Z-1065-03: Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay…
FDA device recall · Class III · Zeus Scientific Inc
Key facts
| Recall number (Z-number) | Z-1065-03 |
|---|---|
| Recall event | 26562 |
| Product | Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B |
| Product code | LFX |
| Recalling firm | Zeus Scientific Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 25, 2004 |
| 510(k) numbers | K984180 |
| FEI number | 2242436 |
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