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U.S. Department of Health and Human Services

Class 2 Device Recall BioFire FilmArray Gastrointestinal (GI) Panel

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 Class 2 Device Recall BioFire FilmArray Gastrointestinal (GI) Panelsee related information
Date Initiated by FirmMay 16, 2024
Date PostedAugust 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2514-2024
Recall Event ID 94992
510(K)NumberK140407 K143005 K160459 K230404 
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
ProductBIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
Code Information Part Number: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 0081538102011: All unexpired products are potentially impacted if used in conjunction with the Remel Cary Blair transport medium Part Number: RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011 All unexpired products are potentially impacted if used in conjunction with the Remel Cary Blair transport medium Remel Cary-Blair Transport Medium lot numbers: 743930 769240 712258 782425 732357 742049
FEI Number 3002773840
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information ContactCustomer Support Department
800-736-6354 Ext. 5
Manufacturer Reason
for Recall		Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 07/11/2024, the firm emailed an "URGENT FIELD SAFETY NOTICE" to customers informing them the firm has identified an increased risk of false positive Vibrio/Vibrio Cholerae results when the BIOFIRE GI Panel is used with certain lots of Remel" Cary-Blair transport medium (see Appendix A - Affected Remel" Cary-Blair Lots). Customers are instructed to: -If the BIOFIRE GI Panel is used in conjunction with certain lots of Remel" Cary-Blair (Lot # 743930, 769240, 712258, 782425, 732357, and 742049), positive results for Vibrio/Vibrio Cholerae should be confirmed by another method prior to reporting the test results. -Distribute this information to all appropriate personnel in your laboratory, retain a copy for your files, post this letter in or near the laboratory, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. -Complete the Acknowledgement Form in Attachment A and return it to usfieldactions@biomerieux.com, so that bioMrieux may acknowledge your receipt of this notification. It is important that you return the acknowledgment form to bioMrieux even if you determine this urgent field safety notice does not impact your facility. For assistance or any questions, contact the bioMrieux Technical Support Center by email at BioFireSupport@biomerieux.com or (800) 682-2666. The anticipated turnaround time for email inquiries is 24 48 hours during normal business hours.
Quantity in Commerce67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.
DistributionU.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. O.U.S.: Worldwide - AR, AU, AT, BE, BR, CA, CL, HK, CN, CO, CZ, DE, FI, FR, GR, HU, IN, IT, JP, MX, NL, NO, PH, PL, PT, SG, ZA, KR, ES, SE, CH, TW, TH, TR, GB, AL, DZ, AO, AM, BH, BY, BO, BA, BW, BG, CR, HR, CY, CD, DO, AN, EC, SV, EE, FJ, GE, GU, GT, GN, HT, HN, IS, ID, IQ, IE, IL, CI, CI, JO, KE, KW, LV, LB, LT, MO, MY, ML, MR, MD, MN, MA, MM, NP, NZ, NZ, NI, OM, PK, PA, PG, PY, PE, QA, RO, SA, RS, SI, TN, TR, UY, AE, VE, VN, and ZW.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = PCH
510(K)s with Product Code = PCH
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