Device recall
Z-0353-2023: CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related…
FDA device recall · Class II · Cytocell Ltd.
Key facts
| Recall number (Z-number) | Z-0353-2023 |
|---|---|
| Recall event | 91117 |
| Product | CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781 |
| Product code | MVU |
| Recalling firm | Cytocell Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2024 |
| 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