Immunohistochemistry Antibody Recalled for Potential Weak Staining
Agilent Technologies is recalling certain lots of FLEX Monoclonal Mouse Anti-Human CD20cy antibodies because they may exhibit weak staining that could result in false negative CD20 identification.
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 risk-of-harm medical device recall. The hazard is potential weak staining that could result in diagnostic error, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Agilent Technologies Denmark ApS is recalling FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) immunohistochemistry antibodies. This product is intended for use with the Dako Omnis instrument to label B-cell lineage cells and aid in the classification of B-cell neoplasms.
The recall was initiated because there is potential for weak staining in certain lots, which may result in false negative CD20 identification.
Affected products were distributed nationwide across multiple states in the United States. The recall involves lot numbers 41810156 and 41741883.
The recalled product
- Product
- Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J 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
- false-negative-detection
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 (2)
- Lot numbers:41810156
- 41741883 GTIN
Distribution
Distributed nationwide across the United States.
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