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.
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- January 22, 2020
- Terminated
- April 14, 2021
- Recall Number
- Z-2296-2020
- Quantity
- 5,020 kits
- Firm Location
- Salt Lake City, UT
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).
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 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.
Lot / Code Info
All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.
Root Cause
Under Investigation by firm
Action Taken
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 increased risk of false positive Proteus results (appearing as Enterobacteriaceae/Proteus on the test report) when the BioFire BCID Panel is used with some BACT/ALERT blood culture bottles (see Table 1) with expiration dates of 19SEP2020 and beyond. It lists the following actions to be taken by the customer: the BioFire BCID Panel is used to test BACT/ALERT blood culture bottles (Table 1) with an expiration date of 19SEP2020 and beyond, positive results for Proteus should be confirmed by another method prior to reporting the test results. This letter supersedes all previous communications regarding Proteus false positive results using bioMrieux blood culture bottles. Please complete the accompanying Field Action Acknowledgment of Receipt Form and return to BioFire via one of the listed return methods so that BioFire may acknowledge your receipt of this notification. If customers have any questions or concerns, they should contact the customer service department at Support@biofiredx.com or via telephone by dialing 1.800.735.6544 and selecting option 5 for product technical support. Adverse events may also be reported to FDAs MedWatch Adverse Event Reporting program.