BioFire Joint Infection Panel diagnostic test kit contamination recall
BioFire Diagnostics is recalling its Joint Infection (JI) Panel diagnostic test kits due to contamination that may produce false positive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. The contamination creates a risk of patient harm through false positive diagnostic results that could lead to incorrect clinical management. No illnesses or injuries are reported in the source text, but the hazard is not purely theoretical—contaminated diagnostic tests represent a direct risk-of-harm product.
Plain-English summary
BioFire Diagnostics, LLC is recalling the BioFire Joint Infection (JI) Panel (REF: RFIT-ASY-0138, 30 test kit) due to product contamination.
The contamination may result in false positive test results, which could lead to incorrect diagnostic conclusions and inappropriate clinical decisions for patients being tested for joint infections.
The affected product includes 106 kits containing 3,180 tests with lot numbers 0883425 and 0878825 (DI: 00815381020192). Distribution was worldwide, including nationwide distribution in Texas, North Carolina, Utah, and Maryland, as well as multiple European countries (France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, Finland, Czech Republic, Romania, Slovenia, and Serbia) and other regions (India, Egypt, Lebanon, Morocco, Dominican Republic, and Serbia).
Customers who have received affected kits should discontinue use and contact BioFire Diagnostics for further instructions regarding replacement or return of the product.
The recalled product
- Product
- BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
- Manufacturer
- BioFire Diagnostics, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #s:0883425
- 0878825/DI: 00815381020192
Distribution
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