Device recall
Z-0516-2009: Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a…
FDA device recall · Class II · Quantimetrix Corporation
Key facts
| Recall number (Z-number) | Z-0516-2009 |
|---|---|
| Recall event | 48190 |
| Product | Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals… |
| Product code | JPK |
| Recalling firm | Quantimetrix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 18, 2009 |
| 510(k) numbers | K010598 |
| FEI number | 2020715 |
At a glance
- 1–9 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