FDA Device

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

Hazard

Label provided for substrate vail contained incorrect expiration date.

What You Should Do

Remedy

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

Products

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
Brand
Agilent Technologies, Inc.
UPC
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

Units Affected

63 kits