BioFire Diagnostics recalls FilmArray Pneumonia Panel (Pneumo) REF: RFIT-ASY-0145 due to potential false negative results in pneumonia testing.
Due to manufacturing issue, panels may result in false negative results.
BioFire Diagnostics recalls its FilmArray Pneumonia Panel (Pneumo) because manufacturing issues could cause false negative results. This means the test might incorrectly show no pneumonia when it's actually present, potentially leading to missed diagnoses.
The panels may produce false negative results due to a manufacturing issue. This means the test might show no pneumonia when the patient actually has pneumonia, leading to missed diagnoses and potential health risks.
Healthcare providers using the FilmArray Pneumonia Panel for pneumonia testing are affected. Patients receiving this test could be at risk if the test fails to detect pneumonia.
Check for the FilmArray Pneumonia Panel (Pneumo) with reference number RFIT-ASY-0145. Look for pouch lot number 2NBT22 or kit number 2187822.
Verify the panel's lot number (2NBT22) or kit number (2187822) to confirm if it's affected.
The recall is due to potential false negative results, not safety issues. The panel can still be used but may not detect pneumonia correctly.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected panel.
The recall indicates a risk of false negatives, which could lead to missed diagnoses, but the record does not mention serious injury or death.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2440-2023 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-2440-2023 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.
