# FDA recall Z-1493-2021

> **Cytocell Ltd.** · Class II · device recall initiated 2021-03-19.

## Product

Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

## Reason for recall

Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

## Distribution

US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.

## Key facts

- **Recall number:** Z-1493-2021
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-19
- **Report date:** 2021-05-05

- **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-1493-2021

## Citation

> AI Analytics. FDA recall Z-1493-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1493-2021. Source: US FDA. Licensed CC0.

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