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.

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).

Code information: All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.

Distribution pattern: 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 Salvador, Estonia, France, Gabon, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Phillipines, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Sitzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, Vietnam.