Device recall
Z-0314-2017: SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid…
FDA device recall · Class II · BBI SOLUTIONS OEM LTD
Key facts
| Recall number (Z-number) | Z-0314-2017 |
|---|---|
| Recall event | 74786 |
| Product | SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood |
| Product code | GHH |
| Recalling firm | BBI SOLUTIONS OEM LTD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2018 |
| 510(k) numbers | K905643 |
| FEI number | 3012801636 |
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