BioFire Diagnostics recalls pneumonia test panels due to potential delayed results from manufacturing issues. Affected units have specific lot numbers and expiration dates.
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
BioFire Diagnostics is recalling its Pneumonia Panel test kits because a manufacturing issue might cause delayed results. This could affect healthcare providers using the tests for pneumonia diagnosis.
The test panels have a manufacturing issue that can cause control failures, leading to delayed results. This means healthcare providers might not get timely results for pneumonia testing.
Healthcare providers using the BioFire Pneumonia Panel test kits are most likely affected. The recall targets specific lot numbers and expiration dates.
Check the lot number and expiration date on the panel. Affected units have lot numbers 2147623 (expiring 28-Aug-2024) or 2147523 (expiring 27-Aug-2024).
Look for lot numbers 2147623 or 2147523 with expiration dates of 28-Aug-2024 or 27-Aug-2024.
The recall is due to a manufacturing issue that can cause control failures, potentially leading to delayed test results.
Check the lot number and expiration date. If it matches the affected numbers, contact BioFire Diagnostics for further instructions.
The recall does not mention any risk of injury; the hazard is only about delayed test results.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2682-2024 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-2682-2024 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.
