Device recall
Z-1147-03: Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific…
FDA device recall · Class III · Zeus Scientific Inc
Key facts
| Recall number (Z-number) | Z-1147-03 |
|---|---|
| Recall event | 26578 |
| Product | Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO. |
| Product code | MID |
| Recalling firm | Zeus Scientific Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 20, 2003 |
| 510(k) numbers | K984173 |
| 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