BioFire Diagnostics recalls Respiratory Panel 2.1 plus Kit (REF: 423740) for possible false negative results from manufacturing errors. Affected units may need replacement.
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
BioFire Diagnostics is recalling its Respiratory Panel 2.1 plus Kit (REF: 423740) because a manufacturing error could cause false negative results. This means test results might be inaccurate, potentially leading to missed diagnoses.
A manufacturing error in the panel could cause the test to show a negative result when the patient actually has a respiratory infection. This might lead to missed diagnoses if the test is not properly functioning.
Healthcare providers using the BioFire Respiratory Panel 2.1 plus Kit for respiratory testing are likely affected. Those testing patients for respiratory infections could be at risk of inaccurate results.
Check for the product name 'BioFire Respiratory Panel 2.1 plus Kit' with reference number 423740. The lot number 1475424 is also associated with this recall.
Verify the product name, reference number 423740, and lot number 1475424 to confirm if your unit is affected.
The recall is for possible false negative results due to a manufacturing error, which could lead to missed diagnoses. It is not an immediate safety hazard.
Check for the product name 'BioFire Respiratory Panel 2.1 plus Kit' with reference number 423740 and lot number 1475424.
The recall does not specify a remedy, so contact BioFire Diagnostics for guidance on next steps.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-1877-2025 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-1877-2025 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.
