FDA recall Z-1384-2022

Agilent Technologies, Inc. · Class III · device

Product

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

Reason for recall

Label provided for substrate vail contained incorrect expiration date.

Distribution

U.S. Nationwide distribution in the states of NY and VA.

Key facts

Status: Ongoing
Initiation date: 2022-05-20
Report date: 2022-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Santa Clara, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1384-2022