BioFire Diagnostics recalls Pneumoplus test kits with specific part numbers due to increased false negative results after 6 months of use. Affected kits may not detect pneumonia accurately.
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
BioFire Diagnostics is recalling certain Pneumoplus pneumonia test kits because they may give false negative results after 6 months of the expiration date. This means the tests could miss pneumonia infections when they should be detected.
The test kits may produce false negative results after 6 months of the expiration date. This means they might not detect pneumonia infections when the infection is actually present, leading to potential missed diagnoses.
Healthcare providers using the recalled Pneumoplus test kits are most at risk. Patients relying on these tests for accurate pneumonia diagnosis could be affected if the kits fail.
Check the part number on the kit: RFIT-ASY-0143, RFIT-ASY-0142, RFIT-ASY-0144, or RFIT-ASY-0145. The unique device identifier (UDI) numbers are 00815381020314, 00815381020321, 00815381020178, or 00815381020185.
Review the part number and unique device identifier (UDI) on the test kit to confirm if it is affected.
The recall is due to real-time stability study failures that increased the rate of false negative results between 6 to 12 months of the expiration date.
Check the part number: RFIT-ASY-0143, RFIT-ASY-0142, RFIT-ASY-0144, or RFIT-ASY-0145. The unique device identifier (UDI) numbers are 00815381020314, 00815381020321, 00815381020178, or 00815381020185.
The official recall notice does not specify a remedy or action for affected kits.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2040-2021 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-2040-2021 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.
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.
