Device recall
Z-0008-2017: Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution)…
FDA device recall · Class II · Microgenics Corporation
Key facts
| Recall number (Z-number) | Z-0008-2017 |
|---|---|
| Recall event | 74982 |
| Product | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained… |
| Product code | OUF |
| Recalling firm | Microgenics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2017 |
| 510(k) numbers | K122766 |
| FEI number | 3010939897 |
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