---
title: "CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell relate... — FDA record Z-0353-2023 | Is It on Recall"
description: "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 chromos"
url: https://isitonrecall.com/recall/fda-device-z-0353-2023-cytocell-bcl11b-proximal-in-fitc-spectrum-ldt-for-investigation-t-cell-related-malignancy-this-devic/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte ... — FDA record Z-0353-2023

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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
- **Classification**: Class II
- **Recalling firm**: Cytocell Ltd.
- **Quantity**: Not supplied
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0353-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0353-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot RD22/230/10 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

TX

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Dec 7, 2022
- **Recall initiation date**: Oct 27, 2022
- **Center classification date**: Dec 1, 2022
- **Termination date**: Dec 27, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0353-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Cytocell Ltd. records](https://isitonrecall.com/brand/cytocell-ltd/)