FDA Medical devices recall ·
FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26… recall
- Recall number
- Z-2563-2025
- Date
- (initiated August 11, 2025)
- Company / brand
- Agilent Technologies Denmark ApS
42 PRODUKTIONSVEJ, Glostrup, N/A, Denmark - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4145
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 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
Why was it recalled?
Their is the potential for weak staining which may result in false negative CD20 identification.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number: 41700704, 41810164, UDI: 05700572033042
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.
States: Alabama California Colorado Connecticut Florida Georgia Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine Michigan Mississippi North Carolina North Dakota New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina Tennessee Texas Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2563-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.