Agilent Technologies, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1384-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: May 20, 2022

Date Posted: July 20, 2022

Recall Number: Z-1384-2022

Event ID: 90435

Reason for Recall:

Label provided for substrate vail contained incorrect expiration date.

Status: Ongoing

Product Quantity: 63 kits

Code Information:

Kit Model Number: K589911-2 UDI-DI Code for Kit: 0 5700571 11286 1 Lot Numbers: 06586309; 06646626; Vial Material Number: K859911-21512 Lot Number: 06646739 Lot Number: 06586327

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated