CellMek SPS
Brand(s)
Last updated
Summary
Product
CellMek SPS
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 |
|---|---|---|
| CellMek SPS | All lots. | C44603 |
Issue
Issue #1- The instructions for use states that the dead volume for tubes in cassette B is 750ul and cassette E is 1300ul. However, testing shows that the dead volumes are actually 1582ul and 2093ul.
Issue # 2- Cassette type E is not rocked prior to aspirating the specimen.
Recall start date: August 27, 2025
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-78025
Get notified
Receive notifications for new and updated recalls and alerts by category.