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Health Canada Medical devices

Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD

Issued July 18, 2025
Issue
BD has observed an increasing trend in complaints related to the BD Trucount™ Controls Kit, specifically due to incorrect standard deviation (SD) values for the low and high control beads on the labeling of the kit, which compromises the accurate calculation of bead counts. Recall start date: July 8, 2025
Hazard description
Performance
Product
Product name
Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD
Reference
ID
RA-77741