Recall Z-1944-2021 ยท QBH Lower Respiratory Microbial Nucleic Acid Detection System
BioFire Diagnostics, LLC
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
| Date | Apr 16, 2021 |
| Status | Terminated |
| Reason | Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process. |
| Root cause | Under Investigation by firm |
| Action | On 04/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via email informing its customers of an issue identified in the manufacturing process which might contribute to elevated rates of false positive/false negative results and control failures while using the pneumonia panel. Customer are instructed to: 1) Immediately examine their inventory for product identified in this recall. 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its st |
| Quantity | 9 kits (U.S. only) |
| Distribution | U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180966 | FilmArray Pneumonia Panel Biofire Diagnostics, LLC, Nov 9, 2018 |