Recall Z-0148-2027— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2026-08-12. It names one FDA 510(k) clearance: K243222. Product: Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory 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.