BioFire Diagnostics recalls Respiratory Panel 2.1 (RP2.1) with REF 423742 due to potential false negative results. Affected units have specific lot numbers and expiration dates.
Due to manufacturing issue, panels may result in false negative results.
BioFire Diagnostics is recalling Respiratory Panel 2.1 (RP2.1) with REF 423742 because manufacturing issues could cause false negative results. This means tests might incorrectly show no infection when one is present, potentially leading to missed diagnoses.
The panels may produce false negative results due to a manufacturing issue. This means the test might show a patient is not infected when they actually are, leading to missed diagnoses and potential spread of infection.
Healthcare providers using the BioFire Respiratory Panel 2.1 for respiratory testing are likely affected. Patients relying on accurate test results could be at risk of undiagnosed infections.
Check for the product name 'BioFire Respiratory Panel 2.1 (RP2.1)' with reference number 423742. Affected units have specific pouch lot numbers (e.g., 2MRG22, 2N0Z22) and expiration dates listed in the recall notice.
Review the pouch lot number and kit number on the product to see if it matches the affected lots listed in the recall.
BioFire Diagnostics is recalling Respiratory Panel 2.1 (RP2.1) with reference number 423742 due to a manufacturing issue that may cause false negative results.
Check the pouch lot number and kit number on the panel. Affected units have specific lot numbers like 2MRG22, 2N0Z22, and expiration dates listed in the recall notice.
No action is needed if your panel does not match the affected lot numbers and expiration dates listed in the recall.
We’ve drafted a message you can send BioFire to request your refund or repair — edit it as you like.
Subject: Recall Z-2439-2023 — BioFire BioFire Hello, I own a BioFire that is covered by recall Z-2439-2023 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.
