FilmArray Gastrointestinal (GI) Panel recallZ-0703-2024 · BioFire Diagnostics, LLC · initiated Nov 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5.
Recall details
- Recall number
- Z-0703-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 27, 2023
- Posted by the FDA
- Jan 10, 2024
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 53 Kits
- Product code
- PCH
- FDA submissions
- K140407, K143005, K160459, K230404
- Distribution
- US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Product description
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Code information (models, lots, serial numbers)
UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0116Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System6 recalls2 deaths24 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K140407, K143005, K160459, K230404 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- FilmArray® Gastrointestinal (GI) Panel RFIT-ASY-0104Biofire Diagnostics, LLC · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93526).
- Z-0704-2024 · Open, ClassifiedThe BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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