FDA-Device2021-02-24Class II
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.
Cairn Diagnostics
Hazard
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Sold states
US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
Affected count
103 kits
Manufactured in
105 Westpark Dr Ste 150, N/A, Brentwood, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1128-2021Don't want to check this manually?
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