BioFire Diagnostics recalls GI Panel devices due to elevated false positives for Campylobacter and Cryptosporidium. Affected units have expiration dates from October 2019 onward. No remedy specified in recall notice.
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
BioFire Diagnostics is recalling its GI Panel diagnostic devices because they've found higher rates of false positive results for Campylobacter and Cryptosporidium. This could lead to incorrect health diagnoses if used without proper verification.
The test can produce false positive results for Campylobacter and Cryptosporidium, meaning it might indicate an infection when none exists. This could lead to unnecessary treatments or anxiety for patients. The risk is not immediate or life-threatening.
Healthcare providers using the GI Panel for diagnostic testing are likely affected. Those testing for gastrointestinal infections may be at risk of incorrect results.
Check if your GI Panel has an expiration date of 23 October 2019 or later. The product is sold under BioFire Diagnostics, LLC with reference numbers RFIT-ASY-0104 or RFIT-ASY-0116.
Verify the expiration date on your GI Panel; affected units have dates from October 2019 onward.
No, the recall is for potential false positive results, which could lead to incorrect diagnoses but does not pose an immediate risk of injury.
The recall notice does not specify a remedy, so no action is required beyond checking the expiration date.
Check for an expiration date of 23 October 2019 or later on the GI Panel, with reference numbers RFIT-ASY-0104 or RFIT-ASY-0116.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1242-2019 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1242-2019 from BioFire 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.
