Recall Z-0150-2027— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2026-08-12. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results.
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-12
- Firm location
- Salt Lake City, UT, United States
Product description
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
Reason for recall
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Data sourced from openFDA. This site is unofficial and independent of the FDA.