# FDA recall Z-0814-2022

> **Cytocell Ltd.** · Class III · device recall initiated 2022-02-04.

## Product

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique  allows the visualisation of DNA sequences upon chromosome  Catalog Number: LPH046-A

## Reason for recall

May show unexpected locus specific signals in addition to those at 14q32.

## Distribution

MN

## Key facts

- **Recall number:** Z-0814-2022
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-04
- **Report date:** 2022-03-30
- **Termination date:** 2024-11-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0814-2022

## Citation

> AI Analytics. FDA recall Z-0814-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0814-2022. Source: US FDA. Licensed CC0.

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