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FDA · Medical device recall

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY…

Recall started · FDA enforcement report Aug. 14, 2024 Class II

Reason
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Status
Ongoing
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.…

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Enforcement report date
Aug. 14, 2024
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
BioFire Diagnostics, LLC
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 stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
Reason
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Distribution pattern
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.
Quantity
67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.
Codes and lots
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
Recall started
May 16, 2024
Voluntary or mandated
Voluntary: Firm initiated
Device type
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Root cause (FDA)
Under Investigation by firm
What the company told customers
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.
Recall number
Z-2514-2024

What the record says about this device

A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.

Four steps: a device, the reason the record gives, the record's wordsA simplified drawing of a medical device with a mark for the reason the record gives. Left, for comparison: the same drawing without what the record names. Right: this record.1 The product: BIOFIRE FILMARRAY Gastrointestinal (GI)…2 The record describes a result that wrongly reads positive or high3 What the record says4 What the record lists+?+?FOR COMPARISONthe same drawing, withoutwhat the record namesTHIS RECORDwhat the record names,step by stepfalse positive

“Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.”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., FDA enforcement report, 2024-08-14. The caption is the record's own words.

A generic device, not the product. The mark follows the record's own words.

If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.

FDA device name: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming and nationwide

This recall among the others

  • FDA's enforcement report came 90 days after the firm started the recall. For half of the 1,034 FDA medical device recall events reported in 2024 with a start date, it took 51 days or fewer (by year).
  • BioFire Diagnostics: 13 other recalls or notices on this site in the three years before this one (from Aug. 15, 2021).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-2514-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-2514-2024, Aug. 14, 2024. "BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY." PlainRecords, https://plainrecords.com/recall/device/z-2514-2024/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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