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Health Canada Medical devices

CellMek SPS

Issued September 4, 2025
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
Hazard description
Performance
Product
Product name
CellMek SPS
Reference
ID
RA-78025