Z-1128-2021 Class II Terminated
FDA device recall Z-1128-2021 was initiated by Cairn Diagnostics on January 8, 2021 and is designated Class II. Reason for recall: Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates The recall status is terminated (terminated August 9, 2023). Affected quantity: 103 kits.
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