The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE
Summary
The FDA issued a Class II for The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic aci by BioFire Diagnostics, LLC. Reason: A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could.
Details
Source
Device Recall
External ID
Z-0704-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
The 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.
Lot/Code Info: UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024
Quantity Affected: 57 Kits
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.
Distribution
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-27
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioFire Diagnostics, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioFire Diagnostics, LLC have FDA actions?
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0704-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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