Agilent Technologies Denmark ApS: Medical Device Recall in 2025 - (Recall #: Z-2565-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J 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

Product Classification:

Class II

Date Initiated: August 11, 2025

Date Posted: September 24, 2025

Recall Number: Z-2565-2025

Event ID: 97421

Reason for Recall:

Their is the potential for weak staining which may result in false negative CD20 identification.

Status: Ongoing

Product Quantity: 67

Code Information:

Lot numbers:41810156, 41741883 GTIN

Distribution Pattern:

US 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.

Voluntary or Mandated:

Voluntary: Firm initiated