Home / Recalls / AGILENT TECHNOLOGIES INC./US / Z-1358-2023

Z-1358-2023 Class III Ongoing

Recalled by AGILENT TECHNOLOGIES INC./US — Kirkland, WA

FDA device recall Z-1358-2023 was initiated by AGILENT TECHNOLOGIES INC./US on February 17, 2023 and is designated Class III. Reason for recall: Distributed sample collection kit with an unapproved instruction for use. The recall status is ongoing. Affected quantity: 560 kits.

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