Recall Z-2296-2020 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BioFire Diagnostics, LLC
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
| Date | Jan 22, 2020 |
| Status | Terminated |
| Reason | There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours). |
| Root cause | Under Investigation by firm |
| Action | The firm's recall strategy is notification of all customers that have ordered the FilmArray BCID Panel using Urgent: Medical Device Correction, FSCA 4593 Letters. The letters to US customers were sent via FedEx to The US letters were mailed on January 22, 2020, via FedEx Overnight, with delivery on January 23, 2020 to the Recall Coordinator/MicroLab Director for all organizations that have ordered FilmArray BCID kits.. The OUS customer communication was issued by bioMrieux (parent company) on January 24, 2020. The letter informed customers that BioFire Diagnostics, LLC has identified an incr |
| Quantity | 5,020 kits |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austria, Australia, Azerbaijan, Belgium, Bosnia-Herz., Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Columbia, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL Biofire Diagnostics, Inc., Jun 21, 2013 |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC, Jan 30, 2015 |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch Biofire Diagnostics, LLC, Mar 15, 2016 |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel Biofire Diagnostics, LLC, Jul 5, 2018 |