AGILENT TECHNOLOGIES INC./US: Medical Device Recall in 2023 - (Recall #: Z-1358-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

Product Classification:

Class III

Date Initiated: February 17, 2023

Date Posted: April 19, 2023

Recall Number: Z-1358-2023

Event ID: 91863

Reason for Recall:

Distributed sample collection kit with an unapproved instruction for use.

Status: Ongoing

Product Quantity: 560 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated