Flex Monoclonal Mouse Anti-Human CD20CY, Clone L26, Ready-To-Use (Dako Omnis)
Last updated
Summary
Product
Flex Monoclonal Mouse Anti-Human CD20CY, Clone L26, Ready-To-Use (Dako Omnis)
Issue
Medical devices - Performance
What to do
| Customers to be notified with instructions to follow. |
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26, Ready-To-Use (Dako Omnis) | 41700704 | GA604 |
| Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26, Ready-To-Use (Dako Omnis) | 41810164 | GA604 |
Issue
Weak staining has been observed in a few cases where GA604 was used to stain CLL/SLL tissue samples for CD20. This weak staining has not been observed in the majority of cases where GA604 was used to test CLL/SLL tissue. As a reminder, the diagnosis of CLL/SLL is made in the context of the histologic appearance by hematoxylin and eosin (H&E) staining, with the aid of a panel of immunohistochemical markers (routinely including other B cell markers such as PAX 5 or CD79), ancillary studies (e.g. flow cytometry on peripheral blood or bone marrow), and clinical information.
Recall start date: July 28, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies
| Agilent Technologies Singapore (International) Pte Ltd. |
|
No. 1 Yishun Avenue 7, Singapore, Singapore, 768923 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-78022
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