Quick Facts at a Glance
- Recall Date
- August 11, 2025
- Hazard Level
- HIGH
- Brand
- Agilent Technologies Denmark
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Agilent Technologies Denmark
- Product type
- CD20 monoclonal antibody for immunohistochemistry
- Model numbers
- GA60461-2CN
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 11, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Their is the potential for weak staining which may result in false negative CD20 identification.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Agilent Technologies Denmark ApS or your healthcare provider for instructions. Notification method: N/A
About This Product
FLEX Monoclonal Mouse Anti-Human CD20cy antibody kit, clone L26, is used for immunohistochemistry with the Dako Omnis instrument to label B-cell lineage cells and aid in classifying B-cell neoplasms.
Why This Is Dangerous
Weak staining can lead to a false negative CD20 result, potentially affecting diagnostic conclusions and patient management.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Laboratories may need to re-test samples or switch to alternative antibodies, potentially delaying diagnoses and increasing labor and cost.
Practical Guidance
How to identify if yours is affected
- Check model GA60461-2CN on the vial or packaging
- Confirm usage with Dako Omnis instrument and recall status
Where to find product info
Label on the product and recall notice; manufacturer recall page and FDA enforce page
What timeline to expect
Refunds or replacements expected within 4-6 weeks after submission of a claim
If the manufacturer is unresponsive
- Escalate with the hospital or lab purchasing department
- File a formal recall complaint with the manufacturer
- Consult the FDA recall public portal for guidance
How to prevent similar issues
- Verify lot numbers before use in any run
- Keep a current list of approved antibodies for IHC workflows
- Ensure instrument compatibility when selecting antibodies
- Check for recall notices before procurement in the future
Documentation advice
Retain recall notice, product packaging, lot numbers, and correspondence with the manufacturer; document affected test results and any retests.
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Product Details
Model: GA60461-2CN. Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis). Component: Not applicable. Distribution: Nationwide in the United States. Lot numbers: 41781549, 41762487, 41651581. Quantity recalled: 65. Sold by: Not specified. Price: Not specified. Country of origin: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- GA60461-2CN model
- Weak-staining risk leading to false negatives
- Distributed nationwide in the U.S.
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