Recall MonitorHealth Products
Flex Monoclonal Mouse Anti-Human CD20CY, Clone L26, Ready-To-Use (Dako Omnis)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Pathology
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
Recall class: Type II
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