BioFire recalls Respiratory Panel 2.1 (RP2.1) REF 423742 due to increased false negative results in PCR tests. Affected units have UDI code 00815381020529.
Due to increase in false negative results
BioFire is recalling its Respiratory Panel 2.1 (RP2.1) REF 423742 PCR test kits because they may produce false negative results. This means the test might incorrectly show a negative result when the person actually has a respiratory infection, potentially leading to missed diagnoses.
The test may give false negative results, meaning it could show a patient does not have a respiratory infection when they actually do. This could lead to missed diagnoses and delayed treatment. The issue is related to the test's accuracy, not physical harm.
Healthcare providers using the BioFire Respiratory Panel 2.1 (RP2.1) REF 423742 for testing patients. Those most at risk are clinicians who rely on this test for accurate diagnosis of respiratory infections.
Check for the product name 'BIOFIRE Respiratory Panel 2.1 (RP2.1)', reference number 423742, and UDI code 00815381020529. The kit may also have a pouch lot number 3VLB25 and kit lot number 1872125.
Review your test results to ensure they are accurate, as false negatives may occur with this specific kit.
The BioFire Respiratory Panel 2.1 (RP2.1) REF 423742 may produce false negative results, meaning it could incorrectly show a negative result when a respiratory infection is present.
Look for the product name 'BIOFIRE Respiratory Panel 2.1 (RP2.1)', reference number 423742, and UDI code 00815381020529. The kit may also have a pouch lot number 3VLB25 and kit lot number 1872125.
The recall record does not specify a remedy, so there is no action required beyond checking results for accuracy.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-2936-2026 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-2936-2026 from BioFire. 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.
