Device recall
Z-2622-2024: Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product…
FDA device recall · Class III · DRG International, Inc.
Key facts
| Recall number (Z-number) | Z-2622-2024 |
|---|---|
| Recall event | 95021 |
| Product | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva. |
| Product code | CDZ |
| Recalling firm | DRG International, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K052649 |
| FEI number | 2245285 |
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