FDA-Device2026-10-21Class IIPROCESSING DEFECT
BioFire Joint Infection Panel recalled for potential false positive results
What this means
Specific lots of the BioFire Joint Infection Panel diagnostic test kit may be contaminated, which could cause the test to incorrectly indicate the presence of a joint infection when none exists. The affected lots were distributed worldwide, including across the United States and multiple international locations.
- Check if your facility has one of the affected lot numbers: 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, or 1684726
- If you have affected kits, stop using them and contact BioFire Diagnostics for instructions
- Review any recent test results from these lots with your healthcare provider to determine if retesting is needed
The agency's original wording
Hazard
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.
Affected count
1,186
Manufactured in
515 S Colorow Dr, Salt Lake City, UT, United States
Products
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0150-2027More BioFire Diagnostics recalls
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