CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific… — Class II medical device recall Z-0341-2023
Terminated recall by Cytocell Ltd., reported 2022-12-07, distributed in TX. An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations sp
| Recall number | Z-0341-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytocell Ltd., Cambridge, United Kingdom |
| Recall initiated | 2022-10-27 |
| Classified | 2022-11-30 |
| Reported by FDA | 2022-12-07 |
| Terminated | 2024-12-27 |
| Distributed | TX |
| Quantity | 3 units |
| Lot numbers | RD22/230/11 |
| Model numbers | MPD39782 |
Product
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
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 coordinates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0341-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.