Brentwood, TN, United States
Cairn Diagnostics recalls
1 recall recorded since 2018, most recently on 8 January 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 January 2021
- Terminated
- 9 August 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1128-2021
- 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)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.