# FDA recall Z-2134-2021

> **Cytocell Ltd.** · Class II · device recall initiated 2021-05-17.

## Product

CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A.  analyte specific reagent for in vitro diagnostics

## Reason for recall

The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.

## Distribution

Distribution to US states of  CA, IL, MO, NY, PA, TX, and UT, and Canada.

## Key facts

- **Recall number:** Z-2134-2021
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-17
- **Report date:** 2021-08-04
- **Termination date:** 2022-08-15

- **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-2134-2021

## Citation

> AI Analytics. FDA recall Z-2134-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2134-2021. Source: US FDA. Licensed CC0.

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