Class 3 Device Recall AntiFITCAP CISH Accessory Kit

• Date Initiated by Firm: May 20, 2022
• Create Date: July 14, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1384-2022
• Recall Event ID: 90435
• Product Classification: General purpose reagent - Product Code PPM
• 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
• 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
• Recalling Firm/ Manufacturer: Agilent Technologies, Inc.; 5301 Stevens Creek Blvd; Santa Clara CA 95051-7201
• For Additional Information Contact: Sarah Litton; 669-255-7696
• Manufacturer Reason for Recall: Label provided for substrate vail contained incorrect expiration date.
• FDA Determined Cause: Labeling Change Control
• Action: On 05/20/2022 and 05/27/2022, Agilent Technologies, Inc. had conference calls with the two Medical Laboratory Facilities that were distributed the affected product to inform them of the situation of the incorrect expiration date on the substrate vials (incorrect expiration dated of 6-30-22. The correct expiration date should be 4-30-22 Customer are instructed/informed: - To immediately cease using Anti-FITC-AP CISH Accessory Kit Lot Numbers 06586309 and 06646626, and to return any remaining labels to Agilent, and return any unused kits to Agilent. - That Agilent is completing production of a new lot of the Kit, and will be shipping to customers on Monday, 05/23/2022, to replace those expired kits. Kits will be provided Free of Charge. - To review test data/results from 05/01/2022 onwards as appropriate in accordance with their applicable procedures. On 06/10/2022, an "Urgent Product Removal" letter was emailed to customer informing them of the removal action. For any questions or further assistance, contact Agilent's Field Action Team at fieldactions@agilent.com
• Quantity in Commerce: 63 kits
• Distribution: U.S. Nationwide distribution in the states of NY and VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.