# FDA recall Z-0353-2023

> **Cytocell Ltd.** · Class II · device recall initiated 2022-10-27.

## 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

## Distribution

TX

## Key facts

- **Recall number:** Z-0353-2023
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-27
- **Report date:** 2022-12-07
- **Termination date:** 2024-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2023

## Citation

> AI Analytics. FDA recall Z-0353-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0353-2023. Source: US FDA. Licensed CC0.

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