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U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray Blood Culture Identification Panel

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  Class 2 Device Recall FilmArray Blood Culture Identification Panel see related information
Date Initiated by Firm March 14, 2018
Date Posted April 25, 2018
Recall Status1 Terminated 3 on October 24, 2018
Recall Number Z-1513-2018
Recall Event ID 79514
510(K)Number K130914  K143171  K160457  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
Code Information All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127).  The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact Kristen Kanack, Ph. D.
801-736-6354 Ext. 1330
Manufacturer Reason
for Recall		 There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
FDA Determined
Cause 2		 Material/Component Contamination
Action The recalling firm initiated the recall on several different dates and methods: Via email on 3/14/2018 with the letter dated 3/3/2018 attached, via USPS on 3/23/2018, and via FedEx between 3/24/2018 and 3/28/2018. The recalling firm conducted an expansion and issued letters dated 6/11/2018 via FedEx or USPS on 6/13/2018.
Distribution Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.
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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