Drug recall
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an…
FDA recall event 91117 · Class II · Cytocell Ltd.
Key facts
| Event ID | 91117 |
|---|---|
| Recall numbers | Z-0353-2023 |
| Recalling firm | Cytocell Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in… |
| Initiation date | Oct 27, 2022 |
| Report date | Dec 7, 2022 |
| Termination date | Dec 27, 2024 |
| City | Cambridge |
| Country | United Kingdom |
| FEI number | 3002646096 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: