HIGH

Agilent Technologies Recalls FLEX Monoclonal Antibody Due to Staining Issues

Agilent Technologies Denmark ApS recalled 65 units of its FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 on August 11, 2025. The recall stems from potential weak staining that could lead to false negative CD20 identification. Healthcare providers and patients should stop using the product immediately.

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

Product Details

The recalled product is FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, with catalog number GA60461-2CN. It was distributed nationwide in the U.S. The lot numbers affected include 41781549, 41762487, and 41651581.

The Hazard

The product may show weak staining, potentially resulting in false negative identification of CD20. This could impact the classification of B-cell neoplasms.

Reported Incidents

As of the report date, no specific incidents or injuries have been documented related to the recall. The potential for inaccuracies in test results poses a significant risk.

What to Do

Stop using the product immediately. Follow the recall instructions provided by Agilent Technologies. Contact your healthcare provider for further guidance.

Contact Information

For more information, reach Agilent Technologies Denmark ApS. Visit their website or call their support line for assistance.

Key Facts

  • Recall date: August 11, 2025
  • Quantity recalled: 65 units
  • Affected lot numbers: 41781549, 41762487, 41651581
  • High hazard level due to potential for false negatives
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
GA60461-2CN
Lot numbers: 41781549
Lot numbers: 41762487
Lot numbers: 41651581
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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