BioFire Diagnostics recalls its Pneumonia Panel Plus due to potential delayed test results from manufacturing control failures. 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 Plus test kits because of a manufacturing issue that might cause delayed results. This could affect healthcare providers using the product for pneumonia testing.
The test kits have a manufacturing issue that can cause control failures, leading to delayed results. This means healthcare providers might not get accurate or timely results for pneumonia testing.
Healthcare providers using the BioFire Pneumonia Panel Plus test kits are likely affected. Those who have the specific lot numbers and expiration dates listed in the recall are at risk.
Check for the lot number 2147723 and expiration date 27-Aug-2024 on the BioFire Pneumonia Panel Plus kit. The product is identified by the UDI-DI code 00815381020314.
Look for the lot number 2147723 and expiration date 27-Aug-2024 on the BioFire Pneumonia Panel Plus kit.
The recalled product is the BioFire FILMARRAY Pneumonia Panel plus with reference number RFIT-ASY-0143.
The product has an increased risk of control failures due to a manufacturing issue, which could lead to delayed test results.
Check for the lot number 2147723 and expiration date 27-Aug-2024 on the kit, or the UDI-DI code 00815381020314.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2683-2024 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-2683-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
