CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation… — Class II medical device recall Z-0353-2023
Terminated recall by Cytocell Ltd., reported 2022-12-07, distributed in TX. Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the posit
| Recall number | Z-0353-2023 |
|---|---|
| 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 | 2022-12-01 |
| Reported by FDA | 2022-12-07 |
| Terminated | 2024-12-27 |
| Distributed | TX |
| Reason classes | labeling |
| Lot numbers | RD22/230/10 |
| Model numbers | MPD39781 |
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
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 version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert
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-0353-2023. 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.