Z-1358-2023 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- February 17, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 560 kits
Product Description
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Reason for Recall
Distributed sample collection kit with an unapproved instruction for use.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None
Code Information
Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159