Official recall record
Bd Trucount™ Control Bead Kit, 30 Test, CE-IVD
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-18
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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