Device recall
Z-1031-03: Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma…
FDA device recall · Class III · Zeus Scientific Inc
Key facts
| Recall number (Z-number) | Z-1031-03 |
|---|---|
| Recall event | 26516 |
| Product | Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ. |
| Product code | DHR |
| Recalling firm | Zeus Scientific Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 3, 2006 |
| 510(k) numbers | K961277 |
| 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