Summary
The FDA issued a Class II for BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 by BioFire Diagnostics, LLC. Reason: Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the .
Details
Source
Device Recall
External ID
Z-2683-2024
Action Date
2024-08-28
Status
Ongoing
Category
device
Product Description
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Lot/Code Info: UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
Quantity Affected: 24 Kits
Reason for Recall
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Distribution
Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-10
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 193 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-2683-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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