# FDA recall Z-2829-2020

> **Cytocell Ltd.** · Class II · device recall initiated 2020-07-17.

## Product

Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

## Reason for recall

A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.

## Distribution

Worldwide distribution - US Nationwide distribution and the country of Canada.

## Key facts

- **Recall number:** Z-2829-2020
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-17
- **Report date:** 2020-08-26
- **Termination date:** 2020-09-30

- **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-2829-2020

## Citation

> AI Analytics. FDA recall Z-2829-2020. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-2829-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*