Device product
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Z-1358-2023
Product summary
- Event
- Event 91863
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 560 kits
- Official record key
device-enforcement:Z-1358-2023
Official wording
Reason: Distributed sample collection kit with an unapproved instruction for use.
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
Distribution pattern: U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None
Derived failure modes
-
Unknown
Distributed sample collection kit with an unapproved instruction for use.