Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Summary
The FDA issued a Class III for Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 by AGILENT TECHNOLOGIES INC./US. Reason: Distributed sample collection kit with an unapproved instruction for use..
Details
Source
Device Recall
External ID
Z-1358-2023
Action Date
2023-04-19
Status
Ongoing
Category
device
Product Description
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Lot/Code Info: Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159
Quantity Affected: 560 kits
Reason for Recall
Distributed sample collection kit with an unapproved instruction for use.
Distribution
U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-17
Company
Kirkland, WA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 135 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (AGILENT TECHNOLOGIES INC./US) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AGILENT TECHNOLOGIES INC./US have FDA actions?
This is the only FDA action we have on record for AGILENT TECHNOLOGIES INC./US in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1358-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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