BioFire Diagnostics, LLC: Medical Device Recall in 2020 - (Recall #: Z-2296-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 22, 2020

Date Posted: June 17, 2020

Recall Number: Z-2296-2020

Event ID: 85550

Reason for Recall:

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).

Status: Terminated

Product Quantity: 5,020 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated