Recall Z-2039-2021 ยท QBH Lower Respiratory Microbial Nucleic Acid Detection System
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
| Date | Jun 7, 2021 |
| Status | Terminated |
| Reason | Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. |
| Root cause | Under Investigation by firm |
| Action | On 06/03/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter via overnight FedEx informing its customer that it has identified a potential for obtaining elevated rates of negative adenovirus results when using the pneumonia panel. The potential false negative results are due to a 10-100x reduction in sensitivity specifically for adenovirus species C when using the pneumonia panel kits within 6 months of expiration. In addition: -The test performance is NOT impacted if kits are more than 6 months from expiration date. -Performance for other adenovirus species (e.g. A |
| Quantity | 4,462 kits (Globally) |
| Distribution | U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180966 | FilmArray Pneumonia Panel Biofire Diagnostics, LLC, Nov 9, 2018 |