Device recall
Z-1454-2015: STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC…
FDA device recall · Class II · Focus Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1454-2015 |
|---|---|
| Recall event | 70856 |
| Product | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic. |
| Product code | OYP |
| Recalling firm | Focus Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 23, 2015 |
| 510(k) numbers | K120986 |
| FEI number | 2023365 |
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