Immunohistochemistry antibody recall due to weak staining risk
Agilent Technologies is recalling FLEX CD20cy antibodies used in immunohistochemistry because weak staining may cause false negative results in B-cell lymphoma 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 medical device recall for an in vitro diagnostic. The hazard is stated as potential (not confirmed harm reported). No illnesses, injuries, or deaths are reported. However, false negative results in cancer diagnosis represent a significant risk of diagnostic harm. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3.
Plain-English summary
Agilent Technologies Denmark ApS is recalling FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) antibodies used in immunohistochemistry (Catalog Number GA60461-2CN).
The recall affects 65 units distributed nationwide across the United States. The affected lot numbers are 41781549, 41762487, and 41651581.
Weak staining of the antibody may result in false negative CD20 identification. This could impair the accurate classification of B-cell derived neoplasms (lymphomas and other B-cell malignancies) during pathology testing. Laboratories should discontinue use of the affected lot numbers and contact Agilent Technologies for replacement materials or further guidance.
The recalled product
- Product
- Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use i
- Manufacturer
- Agilent Technologies Denmark ApS
- Hazard
- weak-staining
- false-negative
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 numbers: 41781549
- 41762487
- 41651581 GTIN:
Distribution
Distributed nationwide across the United States.
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