Medical Device

Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30

Recall date: 2026-10-21 · Source: FDA_DEVICE

Brand / Firm

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 for recall

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Units affected

1,186

Description

View official recall notice →