Device recall
Z-2134-2021: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number…
FDA device recall · Class II · Cytocell Ltd.
Key facts
| Recall number (Z-number) | Z-2134-2021 |
|---|---|
| Recall event | 88138 |
| Product | CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics |
| Product code | MVU |
| Recalling firm | Cytocell Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2022 |
| FEI number | 3002646096 |
At a glance
- None 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