Device recall
Z-2012-2012: Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical…
FDA device recall · Class III · Critical Diagnostics
Key facts
| Recall number (Z-number) | Z-2012-2012 |
|---|---|
| Recall event | 62281 |
| Product | Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated… |
| Product code | OYG |
| Recalling firm | Critical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 16, 2012 |
| 510(k) numbers | K111452 |
| FEI number | 3008661376 |
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