FDAJanuary 8, 2021device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
What to do
FDA enforcement status: Terminated
Brands named
cairn diagnosticscairn
Recall history
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