Cairn Diagnostics recalls 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of g…

Recall date

January 8, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1128-2021

FDA classification

Class II

Brand / firm

Cairn Diagnostics

Sold / distributed

US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.

Why it was recalled

Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.