Health product recall

Leukosure Enumeration Kit

Last updated

Summary

Product
Leukosure Enumeration Kit
Issue
Medical devices - Performance
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
5621090K

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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