# FDA recall Z-2323-2021

> **Cytocell Ltd.** · Class II · device recall initiated 2021-05-27.

## Product

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

## Reason for recall

May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

## Distribution

US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.

## Key facts

- **Recall number:** Z-2323-2021
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-27
- **Report date:** 2021-08-25
- **Termination date:** 2022-05-09

- **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-2323-2021

## Citation

> AI Analytics. FDA recall Z-2323-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2323-2021. Source: US FDA. Licensed CC0.

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