Device recall
Z-0214-05: Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit…
FDA device recall · Class III · Zeus Scientific Inc
Key facts
| Recall number (Z-number) | Z-0214-05 |
|---|---|
| Recall event | 29963 |
| Product | Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test… |
| Product code | MID |
| Recalling firm | Zeus Scientific Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 3, 2006 |
| 510(k) numbers | K981021 |
| 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