FDA recall Z-2565-2025

Agilent Technologies Denmark ApS · Class II · device

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-08-11
Report date
2025-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Glostrup, N/A, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2565-2025