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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

FLEX CD20cy (Dako Omnis) Antibody Recalled for Potential False Negative Risk

Agency Publication Date: September 15, 2025
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Summary

Agilent Technologies Denmark ApS has recalled approximately 4,277 units of FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis). The recall was initiated because the product may produce weak staining, which could lead to false negative identifications of CD20. This laboratory product is used in medical testing to help classify certain types of B-cell tumors. Consumers should contact the manufacturer or their distributor to arrange for a return or replacement.

Risk

Weak staining may result in B-cells not being identified correctly, potentially leading to a false negative result. This can cause medical professionals to misclassify tumors, which may delay or alter correct diagnosis and treatment for B-cell related cancers.

What You Should Do

  1. This recall affects FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) with catalog numbers GA60461-2, GA60461-2CN, and GA60461-2J.
  2. Check your laboratory inventory for the following affected lot numbers: 41700704, 41810164, 41781549, 41762487, 41651581, 41810156, and 41741883.
  3. Stop using the recalled product immediately.
  4. Contact Agilent Technologies Denmark ApS or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Variants: Ready-to-Use (Dako Omnis)
Model / REF:
GA60461-2
Lot Numbers:
41700704
41810164
UDI:
05700572033042

Intended for use in immunohistochemistry together with the Dako Omnis instrument.

Product: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Variants: Ready-to-Use (Dako Omnis)
Model / REF:
GA60461-2CN
Lot Numbers:
41781549
41762487
41651581

Intended for use in immunohistochemistry together with the Dako Omnis instrument.

Product: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis)
Variants: Ready-to-Use (Dako Omnis)
Model / REF:
GA60461-2J
Lot Numbers:
41810156
41741883

Intended for use in immunohistochemistry together with the Dako Omnis instrument.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97421
Status: Active
Manufacturer: Agilent Technologies Denmark ApS
Sold By: Authorized medical laboratory distributors; Agilent Technologies
Manufactured In: Denmark
Units Affected: 3 products (4145; 65; 67)
Distributed To: 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

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.