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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.

FDA Recall Z-1128-2021 · Posted None

Recalling FirmCairn Diagnostics
Recall StatusTerminated
Product CodePGE
Date Initiated2021-01-08
Date Terminated2023-08-09
Product Quantity103 kits

Reason for Recall

Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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