Recall Z-0149-2027 · QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
BioFire Diagnostics, LLC
Generic Name: FilmArray Pneumonia Panel plus Generic Name: FilmArray Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
| Date | Oct 13, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On 09/03/2026, an "URGENT: MEDICAL DEVICE RECALL (CORRECTION)" Letter was emailed to customers informing them that, bioMrieux internally identified increased rates of KPC unexpected positives in Quality Control (QC) testing of the BIOFIRE FILMARRAY PN Panel, BIOFIRE FILMARRAY PNplus Panel, and BIOFIRE JI Panel. Internal testing reproduced KPC unexpected positive results, suggesting KPC nucleic acid contamination in reagent manufacturing at levels that can lead to false positive results. Customers are instructed to: " Examine inventory for the lots identified in this recall. " If a positive KP |
| Quantity | 3,871 |
| 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 Unite |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumon Biofire Diagnostics, LLC (Biomerieux), Nov 6, 2024 |