Device recall
Z-2923-2018: Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva…
FDA device recall · Class II · Tecan US, Inc.
Key facts
| Recall number (Z-number) | Z-2923-2018 |
|---|---|
| Recall event | 80554 |
| Product | Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended… |
| Product code | NHG |
| Recalling firm | Tecan US, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2020 |
| 510(k) numbers | K150528 |
| FEI number | 1037985 |
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