CLASS II Device recall · Reported 24 Feb 2021 · FDA Enforcement Report
13C-Spirulina Gastric Emptying Breath Test (GEBT) recalled
Cairn Diagnostics is recalling 13C-Spirulina Gastric Emptying Breath Test (GEBT), distributed nationwide in the US. The recall was initiated on 8 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1128-2021
- FDA event ID
- 87186
- Recalling firm
- Cairn Diagnostics, Brentwood, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jan 2021
- FDA classified
- 16 Feb 2021
- Reported
- 24 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Jan 2021 | Recall initiated by company | |
| 16 Feb 2021 | Classified by FDA | +39 days |
| 24 Feb 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
Nationwide CaliforniaGeorgiaKansasMichiganNorth CarolinaNew York
Questions about this recall
Why was it recalled?
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Which lots are affected?
Lot Codes: K021-021R, K021-022
Where was it sold?
US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |