# FDA recall Z-1202-2019

> **Cytocell Ltd.** · Class III · device recall initiated 2019-03-15.

## Product

Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

## Reason for recall

There is an error in the chromomap included in the labeling for the product.

## Distribution

The products were distributed to the following US states: IL, TN.

## Key facts

- **Recall number:** Z-1202-2019
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-15
- **Report date:** 2019-05-01
- **Termination date:** 2020-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Adderbury Banbury Oxfordshire, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1202-2019

## Citation

> AI Analytics. FDA recall Z-1202-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1202-2019. Source: US FDA. Licensed CC0.

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