Device recall
Z-0515-2009: Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a…
FDA device recall · Class II · Quantimetrix Corporation
Key facts
| Recall number (Z-number) | Z-0515-2009 |
|---|---|
| Recall event | 48190 |
| Product | Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient cerebrospinal fluid samples performed manually using a hemocytometer. |
| Product code | JJY |
| Recalling firm | Quantimetrix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 18, 2009 |
| 510(k) numbers | K970862 |
| 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