BioFire Diagnostics, LLC BIOFIRE 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 stoo Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BIOFIRE 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 stoo
Brand
BioFire Diagnostics, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
BioFire Diagnostics, LLC is recalling BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY due to Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026