medical Class II Updated 2021-02-24

Cairn Diagnostics recalls 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Codes: K021-021R, K021-022
View official government recall

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