CD20 antibody lots recalled over weak staining risking false negative results
FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a false negative in a diagnostic stain is a potential harm and no injuries are reported.
Plain-English summary
FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis), model and catalog number GA60461-2J, is being recalled for lot numbers 41810156 and 41741883. The recall covers 67 units distributed across many states.
There is the potential for weak staining, which may result in false negative CD20 identification. The FDA classified the action as Class II.
Laboratories holding these lots should stop using them and follow the manufacturer's instructions on affected stock and on results already reported.
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
- false-negative
- weak-staining
- immunohistochemistry
- class-ii
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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