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U.S. Department of Health and Human Services

Class 2 Device Recall FLEX Monoclonal Mouse AntiHuman CD20cy, Clone L26, ReadytoUse (Dako Omnis)

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 Class 2 Device Recall FLEX Monoclonal Mouse AntiHuman CD20cy, Clone L26, ReadytoUse (Dako Omnis)see related information
Date Initiated by FirmAugust 11, 2025
Date PostedSeptember 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2563-2025
Recall Event ID 97421
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
ProductBrand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
Code Information Lot number: 41700704, 41810164, UDI: 05700572033042
FEI Number 3002806778
Recalling Firm/
Manufacturer		 Agilent Technologies Denmark ApS
42 PRODUKTIONSVEJ
Glostrup Denmark
Manufacturer Reason
for Recall		Their is the potential for weak staining which may result in false negative CD20 identification.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 11, 2025, Agilent Technologies, issued a Urgent Medical Device Correction Notification to affected consignees via E-Mail. Agilent Technologies ask consignees to take the following actions: 1: Please check your inventory and identify if you have the affected product listed in Table 1. Be aware that these products show potential weak staining, which may lead to false negative CD20 identification when used on CLL/SLL tissue samples. 2. If you experience weak staining, please contact Agilent Technical Support for troubleshooting. 3. Please confirm that you have received, read, and understood this Field Safety Notification by completing and signing the enclosed Acknowledgement Form and returning it to fieldactions.notifications@agilent.com. 4. Share this notice with anyone who needs to be aware within your organization and forward to any organization where potentially affected devices may have been transferred.
Quantity in Commerce4145
DistributionUS Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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