Official recall record
Creatine Kinase (CK)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-08-30
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Roche received complaints from US customers for Creatine Kinase (CK) lot 755471 (expired June-2024) on cobas c 311/501/502 and INTEGRA 400 plus about abnormal calibration signals, flagged calibrations (Sens.E) and control recovery issues. Subsequent investigation identified a positive bias at the lower measuring range and a negative bias at the higher measuring range. The issue affects a small number of cassettes of the mentioned lot. Recall Start Date: August 19, 2024
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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