Recall Z-2245-2021 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
| Date | Jul 20, 2021 |
| Status | Terminated |
| Reason | Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error. |
| Root cause | Process control |
| Action | On 07/20/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customer informing them that an issue has been identified in the manufacturing process which might contribute to elevated rates of false negative results while using the BCID Panel. Actions to be taken by customers: 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 standard limited warranty. 3) |
| Quantity | 29 kits |
| Distribution | U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181493 | FilmArray Blood Culture Identification (BCID) Panel Biofire Diagnostics, LLC, Jul 5, 2018 |