Class 2 Device Recall 13CSpirulina Gastric Emptying Breath Test

• Date Initiated by Firm: January 08, 2021
• Create Date: February 16, 2021
• Recall Status: Terminated on August 09, 2023
• Recall Number: Z-1128-2021
• Recall Event ID: 87186
• Product Classification: Gastric Emptying Breath Test - Product Code PGE
• 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.
• Code Information: Lot Codes: K021-021R, K021-022
• FEI Number: 3009091796
• Recalling Firm/ Manufacturer: Cairn Diagnostics; 105 Westpark Dr Ste 150; Brentwood TN 37027-1012
• For Additional Information Contact: Catherine Williams, PhD; 615-376-5464 Ext. 103
• Manufacturer Reason for Recall: Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
• FDA Determined Cause: Under Investigation by firm
• Action: The firm initiated the recall by telephone or email, followed with a telephone call on 01/08/2021. Commercial clients have been instructed not to use GEBT kits and that Cairn will follow up with a recall notice with full instructions on what to do with kits.
• Quantity in Commerce: 103 kits
• Distribution: US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.