Device recall
Z-0521-2021: 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No…
FDA device recall · Class II · Chromsystems Instruments & Chemicals GmbH
Key facts
| Recall number (Z-number) | Z-0521-2021 |
|---|---|
| Recall event | 86699 |
| Product | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. |
| Product code | JIX |
| Recalling firm | Chromsystems Instruments & Chemicals GmbH |
| Recall class | Class II |
| Status | Completed |
| FEI number | 3003951180 |
At a glance
- None 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