Device recall
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
- Recall number
- Z-0150-2027
- Event id
- 99592
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- BioFire Diagnostics, LLC
- Report date
- Oct 21, 2026
- Posted
- Oct 13, 2026
- Initiated
- Aug 12, 2026
- Center classification date
- Oct 13, 2026
- Product code
- QSN
- Device type
- Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- Reason
- Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- Root cause
- Under Investigation by firm
- Quantity
- 1,186
- Code info
- Lot Code: UDI Nos 00815381020192 (30 Kit), 00815381020208 (6 Kit); Model Nos RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit); Lot Numbers 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, 1684726
- Distribution
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Salt Lake City, UT, United States