Cairn Diagnostics recalls 13C-Spirulina Gastr: 13C-Spirulina Gastric Emptying Breath Test kits with lot codes K021-021R and K021-022 may cause false negative results for gastroparesis diagnosis.
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Cairn Diagnostics is recalling specific 13C-Spirulina Gastric Emptying Breath Test kits that could give false negative results for gastroparesis diagnosis. This means the test might miss a serious digestive condition, leading to delayed treatment.
The test uses 13C-Spirulina which can cause unusually high 13CO2-excretion rates. This may lead to false negative results, meaning the test might not detect gastroparesis when it's present.
Adults using the test for gastroparesis diagnosis. Those with symptoms of delayed gastric emptying are most at risk.
Check the lot code on the test kit. Affected kits have lot codes K021-021R or K021-022.
Look for lot codes K021-021R or K021-022 on the test kit.
The test may give false negative results for gastroparesis, meaning it might miss a serious digestive condition.
Check the lot code on the test kit. Affected kits have lot codes K021-021R or K021-022.
No, but you should check the lot code to ensure you have a recalled version.
We’ve drafted a message you can send Cairn Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1128-2021 — Cairn Diagnostics Cairn Diagnostics Hello, I own a Cairn Diagnostics that is covered by recall Z-1128-2021 from Cairn Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
