BEUDAMED
    FDA Recall 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 · Initiated January 8, 2021

    Recall

    Recall Number
    Z-1128-2021
    Event Number
    87186
    Firm
    Cairn Diagnostics
    FEI Number
    3009091796
    Product Code
    PGE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 8, 2021
    Terminated
    August 9, 2023
    Address
    105 Westpark Dr, Ste 150, Brentwood, TN, 37027-1012

    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

    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.

    Distribution

    US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.

    Quantity

    103 kits