FDA Medical Device Recalls (openFDA)
Cairn Diagnostics: 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 number
- Z-1128-2021
- Recalling firm
- Cairn Diagnostics
- 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.
- Status
- Terminated
- Initiated
- 2021-01-08
- Posted
- not on file
- Terminated
- 2023-08-09
- Reason
- Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
- Root 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
- 103 kits
- Distribution
- US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
- Lot, serial or model codes
- Lot Codes: K021-021R, K021-022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PGE
- Firm FEI
- 3009091796
- Firm city
- Brentwood
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28