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U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray Blood Culture Identification (BCID) Panel

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  Class 2 Device Recall FilmArray Blood Culture Identification (BCID) Panel see related information
Date Initiated by Firm January 22, 2020
Create Date June 08, 2020
Recall Status1 Terminated 3 on April 14, 2021
Recall Number Z-2296-2020
Recall Event ID 85550
510(K)Number K130914  K143171  K160457  K181493  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product 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.
Code Information All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact Customer Service Department
801-736-6354 Ext. 5
Manufacturer 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).
FDA Determined
Cause 2		 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 bioM¿rieux (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 bioM¿rieux 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.
Quantity in Commerce 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PEN and Original Applicant = BIOFIRE DIAGNOSTICS, INC.
510(K)s with Product Code = PEN and Original Applicant = BIOFIRE DIAGNOSTICS, LLC
510(K)s with Product Code = PEN and Original Applicant = Biofire Diagnostics, LLC.
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