Leukosure Enumeration Kit
Brand(s)
Last updated
Summary
Product
Leukosure Enumeration Kit
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Leukosure Enumeration Kit |
5621089K |
175621 |
Issue
Affected lots of Leukosure enumeration kit may not be able to acquire 10,000 leukosure fluorosphere events within 300 seconds as outlined in the statement of warnings in the product instructions for use (IFU) pn 175624 revision ee. The issue is due to inadequate lysing of red blood cells.
Recall start date: November 21, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72331
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