Z-1384-2022Class III

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit...

Name: Z-1384-2022 Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit...
Creator: Agilent Technologies, Inc.
Published: 2022-05-20
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2022-05-20 / Open, Classified / root cause: labeling and UDI

FDA source

Agilent Technologies, Inc. began a recall of 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... on 2022-05-20. FDA classified it as Class III and gives the reason as "Label provided for substrate vail contained incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1384-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-05-20
Posted: 2022-07-14
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
Product code: PPM General Purpose Reagent
Reason for recall: Label provided for substrate vail contained incorrect expiration date.
Root cause tag: labeling and UDI
FDA 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 [email protected]
Quantity in commerce: 63 kits
Distribution: U.S. Nationwide distribution in the states of NY and VA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1384-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1384-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-14

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)