FDA Enforcement
Class II
Terminated
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.
Recall: Z-1128-2021
·
Reported February 24, 2021
Enforcement
- Recall Number
- Z-1128-2021
- Event ID
- 87186
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cairn Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- February 24, 2021
- Initiation Date
- January 8, 2021
- Classification Date
- February 16, 2021
- Termination Date
- August 9, 2023
- Address
- 105 Westpark Dr Ste 150, N/A, Brentwood, TN, 37027-1012, United States
Description
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.
Reason
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Code Info
Lot Codes: K021-021R, K021-022
Distribution
US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
Quantity
103 kits