BioFire Diagnostics recalls pneumonia test kits that may give false negative results after 6 months of use. Affected kits have specific part numbers and serial codes. Stop using if expired.
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 recalls certain pneumonia test kits that may produce false negative results after 6 months of the expiration date. This could lead to incorrect health assessments if the test is used on a patient with pneumonia.
The test kits may give false negative results between 6 to 12 months after the expiration date. This means the test might not detect pneumonia when it's actually present, leading to potential misdiagnosis.
Healthcare providers using the FilmArray Pneumonia Panel test kits with specific part numbers are most at risk. Patients relying on these tests for accurate diagnosis may be affected if the test is used after the expiration date.
Check for part numbers RFIT-ASY-0144 or RFIT-ASY-0145 with serial codes 00815381020178 or 00815381020185. These kits were sold in the U.S. between 2017 and 2018.
Verify the test kit's expiration date to ensure it is not expired.
The test kits may produce false negative results between 6 to 12 months after the expiration date, which could lead to incorrect diagnosis of pneumonia.
Part numbers RFIT-ASY-0144 and RFIT-ASY-0145 with serial codes 00815381020178 and 00815381020185.
Check the test kit for part numbers RFIT-ASY-0144 or RFIT-ASY-0145 and serial codes 00815381020178 or 00815381020185.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2039-2021 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-2039-2021 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.
