# FDA recall Z-1099-2021

> **Cytocell Ltd.** · Class II · device recall initiated 2020-12-22.

## Product

Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A    The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric)  to the CRLF2 gene

## Reason for recall

Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.

## Distribution

Domestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-1099-2021
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-22
- **Report date:** 2021-02-17
- **Termination date:** 2022-06-07

- **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-1099-2021

## Citation

> AI Analytics. FDA recall Z-1099-2021. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1099-2021. Source: US FDA. Licensed CC0.

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