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Recall Observatory FDA recall evidence

Device 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

Z-1384-2022

May 20, 2022

Class III

Product summary

Firm
Agilent Technologies, Inc.
Event
Event 90435
Status
Ongoing
Classification
Class III
Quantity
63 kits
Official record key
device-enforcement:Z-1384-2022

Official wording

Reason: Label provided for substrate vail contained incorrect expiration date.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Label provided for substrate vail contained incorrect expiration date.