Recall Z-0994-2024 ยท QBH Lower Respiratory Microbial Nucleic Acid Detection System
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
| Date | Feb 6, 2024 (initiated Dec 14, 2023) |
| Status | Open, Classified |
| Reason | Their is a potential for false positive results when using Pneumonia panel. |
| Root cause | Under Investigation by firm |
| Action | On December 14, 2023, Biomerieux, issued a "Urgent Medical Recall" to affected consignees via: FedEx . Biomerieux asked consignees to take the following actions: 1. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. 2. Use another method to confirm positive results for seasonal Coronavirus from the BIOFIRE Pneumonia Panel or BIOFIRE Pneumonia Panel plus prior to reporting the result (e.g., consider resul |
| Quantity | 274,290 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, 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, WY and the countries of Argentina, Bolivia, Brazil, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180966 | FilmArray Pneumonia Panel Biofire Diagnostics, LLC, Nov 9, 2018 |