Device recall
Z-2434-2019: Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
FDA device recall · Class II · Helena Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2434-2019 |
|---|---|
| Recall event | 81383 |
| Product | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL |
| Product code | JJY |
| Recalling firm | Helena Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 12, 2023 |
| 510(k) numbers | K821982 |
| FEI number | 1618982 |
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