Device recall
Z-0297-2020: SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and…
FDA device recall · Class III · Helena Laboratories, Corp.
Key facts
| Recall number (Z-number) | Z-0297-2020 |
|---|---|
| Recall event | 83925 |
| Product | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems |
| Product code | JBD |
| Recalling firm | Helena Laboratories, Corp. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K982426 |
| FEI number | 1618982 |
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