BioFire Diagnostics recalls Pneumonia Panel (Penumo) REF RFIT-ASY-014: elevated false positives/negatives and control failures due to manufacturing issues. Affected units include specific lot numbers and model.
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
BioFire Diagnostics is recalling its Pneumonia Panel (Penumo) REF RFIT-ASY-0144 because it can give false positive or false negative results and fail controls due to manufacturing issues. This could lead to incorrect pneumonia diagnoses and treatment decisions.
The panel can produce false positive or false negative results and fail control tests due to manufacturing defects. This means it might incorrectly indicate pneumonia when it's not present or miss actual pneumonia cases, leading to wrong treatment decisions.
Healthcare providers using the Pneumonia Panel for testing are most at risk, as inaccurate results could affect patient care decisions.
Check for the product name 'Pneumonia Panel (Penumo)' with part number RFIT-ASY-0144. Affected units include specific lot numbers: Kit Lot# 0938121 and Pouch Lot# 19T621.
Look for the part number RFIT-ASY-0144 and lot numbers Kit Lot# 0938121 or Pouch Lot# 19T621 on the panel packaging.
The recall is due to elevated false positive/false negative results and control failures, which could lead to incorrect diagnoses but does not pose an immediate physical risk.
Check for the part number RFIT-ASY-0144 with Kit Lot# 0938121 or Pouch Lot# 19T621 on the packaging.
The recall does not specify a remedy, so contact BioFire Diagnostics directly for guidance on next steps.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1944-2021 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1944-2021 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.
