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U.S. Department of Health and Human Services

Class 2 Device Recall BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, (Firm Part Number: RFITASY0116)

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  Class 2 Device Recall BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, (Firm Part Number: RFITASY0116) see related information
Date Initiated by Firm November 27, 2023
Date Posted January 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-0703-2024
Recall Event ID 93526
510(K)Number K230404  K160459  K143005  K140407  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
Product BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Code Information UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact Customer Support Department
800-736-6354 Ext. 5
Manufacturer Reason
for Recall		 A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
FDA Determined
Cause 2		 Process control
Action On 11/27/23, recall notices were emailed to laboratory directors who were asked to do the following: Discontinue use and discard any remaining pouches that are subject to this recall. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. Complete and return the acknowledgement form using the following URL: https://www.biofiredx.com/recall5797 Customers with questions can contact Technical Support at biofiresupport@biomerieux.com or via telephone by dialing 1.800.735.6544 and selecting option 5.
Quantity in Commerce 53 Kits
Distribution US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PCH and Original Applicant = Biofire Diagnostics
510(K)s with Product Code = PCH and Original Applicant = BioFire Diagnostics, LLC
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