healthClass IIRecalled on Sep 24, 2025

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not app

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Sold At: Agilent Technologies Denmark ApS(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.)

Recall #: FDA-DEVICE-Z-2565-2025

Source: FDA-ENFORCEMENT

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)  Model/Catalog Number: GA60461-2J  Software Version: Not app

Product Identification

Lot/Batch Codes:
Lot numbers:41810156, 41741883 GTIN

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Summary

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

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact Agilent Technologies Denmark ApS for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.