Immunohistochemistry Antibody Recalled for Weak Staining and Diagnostic Error Risk
Agilent is recalling FLEX Monoclonal Anti-Human CD20cy antibody due to weak staining that may result in false negative B-cell identification. About 4,145 units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a diagnostic laboratory device with potential for false negative results in B-cell identification, representing a risk-of-harm product where injury has not yet been reported. The staining deficiency could affect diagnostic accuracy in cancer classification.
Plain-English summary
Agilent Technologies Denmark ApS is recalling FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis), catalog number GA60461-2. This immunohistochemistry reagent is designed for use with the Dako Omnis instrument to identify B-cell lineage and aid in the classification of B-cell-derived neoplasms.
The recall addresses the potential for weak staining in the antibody preparation, which may result in false negative CD20 identification. This staining deficiency could affect the accuracy of diagnostic results in laboratory testing.
A total of 4,145 units were distributed nationwide, including to facilities in 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, and Wisconsin. The affected lot numbers are 41700704 and 41810164.
The recalled product
- 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
- Manufacturer
- Agilent Technologies Denmark ApS
- Hazard
- weak-staining
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot number: 41700704
- 41810164
- UDI: 05700572033042
Distribution
Distributed nationwide across the United States.
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