Recall Z-1518-2025 · QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
BioFire Diagnostics, LLC
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
| Date | Apr 4, 2025 (initiated Feb 27, 2025) |
| Status | Open, Classified |
| Reason | Increased risk of control failures and false negative test results with multiplexed nucleic acid test. |
| Root cause | Nonconforming Material/Component |
| Action | On February 28, 2025, Biomerieux issued an "Urgent Field Safety Notice" Recall notification to affected consignees via email. The notice described the product, problem and actions to be taken. Biomerieux asked consignees to take the following actions: " Immediately examine your inventory for the lot identified in this field safety notice. " Discontinue use and discard any remaining product from this lot in your possession. bioMrieux will replace the product at no charge in accordance with our standard limited warranty. " Confirm the amount of pouches scrapped (if any) on the attached Acknowl |
| Quantity | 29 kits |
| Distribution | OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181324 | FilmArray Pneumonia Panel plus Biofire Diagnostics, LLC, Nov 15, 2018 |
| K222601 | FilmArray Pneumonia Panel plus Biofire Diagnostics, LLC, Oct 27, 2022 |
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumon Biofire Diagnostics, LLC (Biomerieux), Nov 6, 2024 |