# FDA recall Z-0741-2022

> **Cytocell Ltd.** · Class II · device recall initiated 2022-01-18.

## Product

Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS  Catalog Number: USA-LPH024

## Reason for recall

individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result

## Distribution

US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.

## Key facts

- **Recall number:** Z-0741-2022
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-18
- **Report date:** 2022-03-16
- **Termination date:** 2024-11-08

- **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-0741-2022

## Citation

> AI Analytics. FDA recall Z-0741-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0741-2022. Source: US FDA. Licensed CC0.

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