Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omn
Summary
The FDA issued a Class III for Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 A by Agilent Technologies, Inc.. Reason: Label provided for substrate vail contained incorrect expiration date..
Details
Source
Device Recall
External ID
Z-1384-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 63 kits
Reason for Recall
Label provided for substrate vail contained incorrect expiration date.
Distribution
U.S. Nationwide distribution in the states of NY and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-20
Company
Santa Clara, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Agilent Technologies, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Agilent Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Agilent Technologies, Inc. have FDA actions?
Agilent Technologies, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1384-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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