BioFire Diagnostics recalls Pneumoplus pneumonia test panels due to increased risk of false negatives from control failures. Affected units have specific UDI and lot numbers.
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
BioFire Diagnostics is recalling its Pneumopl: Pneumonia Panel Plus (Pneumoplus) tests because they can give false negative results when used with multiplexed nucleic acid tests. This means the test might miss infections that are actually present.
The test panels can fail to provide accurate results when used with multiplexed nucleic acid tests, leading to false negative results. This means the test might not detect pneumonia when it's actually present, potentially delaying proper treatment.
People who use the Pneumoplus test panels for pneumonia diagnosis, especially those in healthcare settings. The risk is low for most users as the issue affects test accuracy rather than causing immediate harm.
Check for the product name 'Pneumoplus' and the unique device identifier (UDI) 00815381020314 or lot number 0979424. The recall covers specific units sold with these identifiers.
Look for the UDI 00815381020314 or lot number 0979424 on the test panel packaging.
The recall is due to increased risk of control failures and false negative test results when used with multiplexed nucleic acid tests.
Check for the UDI 00815381020314 or lot number 0979424 on the test panel packaging.
The recall record does not specify a remedy, so no action is required beyond checking if your product has the listed identifiers.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1518-2025 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1518-2025 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.
