Recall Z-1128-2021— Cairn Diagnostics
Class II · Terminated
Class II FDA medical device recall by Cairn Diagnostics, initiated 2021-01-08, terminated 2023-08-09. FDA's recall record names no specific 510(k) clearance for this event. 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: Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates.
- Recalling firm
- Cairn Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-08
- Terminated
- 2023-08-09
- Firm location
- Brentwood, TN, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.