Z-1128-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- January 8, 2021
- Termination Date
- August 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103 kits
Product 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 for Recall
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Distribution Pattern
US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
Code Information
Lot Codes: K021-021R, K021-022