BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI
Summary
The FDA issued a Class II for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) by BioFire Diagnostics, LLC. Reason: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium..
Details
Source
Device Recall
External ID
Z-2514-2024
Action Date
2024-08-14
Status
Ongoing
Category
device
Product Description
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 stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
Lot/Code Info: 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
Quantity Affected: 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.
Reason for Recall
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Distribution
U.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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-16
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioFire Diagnostics, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioFire Diagnostics, LLC have FDA actions?
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2514-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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