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Cairn Diagnostics recalls 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of ga
Recalled February 24, 2021 · FDA recall Z-1128-2021 · Cairn Diagnostics
Hazard
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates · FDA Class II
Units
103 kits
Sold at
US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
Description
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
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.
Manufacturer(s)
Cairn Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →