BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Recall
- Recall Number
- Z-0703-2024
- Event Number
- 93526
- Firm
- BioFire Diagnostics, LLC
- FEI Number
- 3002773840
- Product Code
- PCH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 27, 2023
- Posted
- January 10, 2024
- Address
- 515 S Colorow Dr, Salt Lake City, UT, 84108-1248
Description
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
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.
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.
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
53 Kits