Device 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.
Z-1128-2021
Product summary
- Event
- Event 87186
- Status
- Terminated
- Classification
- Class II
- Quantity
- 103 kits
- Official record key
device-enforcement:Z-1128-2021
Official wording
Reason: Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Code information: Lot Codes: K021-021R, K021-022
Distribution pattern: US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
Derived failure modes
-
Unknown
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates