Summary
The FDA issued a Class II for VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 by Luminex Corporation. Reason: It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Tes.
Details
Source
Device Recall
External ID
Z-2024-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Lot/Code Info: UDI/DI , Lot Numbers: 071222022D, 100622022D
Quantity Affected: 114 units
Reason for Recall
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
Distribution
Worldwide and US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-05
Company
Northbrook, IL
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 367 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Luminex Corporation has 26 FDA actions in our database, including 21 recalls and 5 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 (Luminex Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Luminex Corporation have FDA actions?
Luminex Corporation has 26 FDA actions in our database, including 21 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2024-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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