FDA recall Z-1358-2023

AGILENT TECHNOLOGIES INC./US · Class III · device

Product

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

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

Key facts

Status
Ongoing
Initiation date
2023-02-17
Report date
2023-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kirkland, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2023