Device recall
Z-2159-2019: DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human…
FDA device recall · Class II · DRG Instruments GmbH
Key facts
| Recall number (Z-number) | Z-2159-2019 |
|---|---|
| Recall event | 83183 |
| Product | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in… |
| Product code | CDZ |
| Recalling firm | DRG Instruments GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2020 |
| 510(k) numbers | K052649 |
| FEI number | 3002800697 |
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