Recall Z-2440-2023 ยท QBH Lower Respiratory Microbial Nucleic Acid Detection System
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
| Date | Aug 21, 2023 (initiated May 8, 2023) |
| Status | Open, Classified |
| Reason | Due to manufacturing issue, panels may result in false negative results. |
| Root cause | Process design |
| Action | Between the dates of May 8, 2023 - May 11, 2023, Biomerieux ( Parent company of BioFire Diagnostics, LLC) issued an "Urgent: Medical Device Correction" notification to affected consignees via FedEx. Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for product identified in this recall (refer to Table 1). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty. 3. Please complete the accompanyi |
| Quantity | 24 Kits (30 pouches/kit) |
| Distribution | US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia |
| FDA record | Open on fda.gov |