BioFire Diagnostics recalls Pneumonia Panel Plus (Pneumoplus) kits due to potential false positive results. Affected kits include all unexpired lots with UDI 00815381020314.
Their is a potential for false positive results when using Pneumonia panel.
BioFire Diagnostics recalls its Pneumonia Panel Plus (Pneumoplus) test kits because they may give false positive results. This could lead to unnecessary treatments or anxiety for users. The recall covers all unexpired lots of the test kits.
The test kits may produce false positive results when detecting pneumonia, which could lead to unnecessary treatments or anxiety. This happens due to a potential issue with the test's accuracy.
Healthcare providers and labs using the Pneumonia Panel Plus test kits are likely affected. Those who have recently used the test kits may be at risk of false positive results.
Check for the product name 'Pneumonia Panel Plus (Pneumoplus)' and the unique device identifier (UDI) 00815381020314. All unexpired lots of this test kit are affected.
Verify the product name and UDI number on the test kit packaging to confirm if it is affected.
The test kits may produce false positive results when detecting pneumonia, which could lead to unnecessary treatments or anxiety.
Check for the product name 'Pneumonia Panel Plus (Pneumoplus)' and the unique device identifier (UDI) 00815381020314 on the test kit packaging.
No, the recall does not require immediate discontinuation. Affected kits can be checked for the UDI number to determine if they are affected.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0993-2024 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-0993-2024 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.
