# FDA recall Z-1843-2019

> **Cytocell Ltd.** · Class III · device recall initiated 2019-04-26.

## Product

Aquarius D13S319 Plus Deletion Probe, Model LPH068-A    Product Usage:  The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.

## Reason for recall

There is an error in the chromomap on the package insert.

## Distribution

Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI.    The products were distributed to the following foreign countries:  Canada.

## Key facts

- **Recall number:** Z-1843-2019
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-26
- **Report date:** 2019-06-26
- **Termination date:** 2020-07-16

- **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-1843-2019

## Citation

> AI Analytics. FDA recall Z-1843-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1843-2019. Source: US FDA. Licensed CC0.

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