FDA Medical Device Recalls (openFDA)
Agilent Technologies, Inc.: 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
- Recall number
- Z-1384-2022
- Recalling firm
- Agilent Technologies, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2022-05-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- Label provided for substrate vail contained incorrect expiration date.
- Root 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
- 63 kits
- Distribution
- U.S. Nationwide distribution in the states of NY and VA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 2916205
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28