Drug recall
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
FDA recall event 91119 · Class II · Cytocell Ltd.
Key facts
| Event ID | 91119 |
|---|---|
| Recall numbers | Z-0341-2023 |
| Recalling firm | Cytocell Ltd. |
| Product type | Devices |
| Products | CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong… |
| 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: