FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
- Recall number
- Z-0703-2024
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
- Status
- Open, Classified
- Initiated
- 2023-11-27
- Posted
- 2024-01-10
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 53 Kits
- Distribution
- US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
- Lot, serial or model codes
- UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024
- 510(k) numbers
- ["K140407","K143005","K160459","K230404"]
- PMA numbers
- not on file
- Product code
- PCH
- Firm FEI
- 3002773840
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28