Z-0703-2024Class II

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro...

Name: Z-0703-2024 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro...
Creator: BioFire Diagnostics, LLC
Published: 2023-11-27
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2023-11-27 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY... on 2023-11-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0703-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-27
Posted: 2024-01-10
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.
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5.
Quantity in commerce: 53 Kits
Distribution: US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Product codes and lots: UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0703-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0703-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10
Z-0704-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10

Product code PCH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)