# FDA recall Z-1128-2021

> **Cairn Diagnostics** · Class II · device recall initiated 2021-01-08.

## Product

13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

## Reason for recall

Potential for false negative diagnosis of gastroparesis.  Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

## Distribution

US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.

## Key facts

- **Recall number:** Z-1128-2021
- **Recalling firm:** Cairn Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-08
- **Report date:** 2021-02-24
- **Termination date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brentwood, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1128-2021

## Citation

> AI Analytics. FDA recall Z-1128-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1128-2021. Source: US FDA. Licensed CC0.

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