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Creatine Kinase (CK) — recall 75993

Health Canada — Medical Devices · Canada · 2024-08-30 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 75993
Date of alert: 2024-08-30
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Chemistry
Product type: Medical devices

Reported risk: 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

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/creatine-kinase-ck

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Creatine Kinase (CK) — recall 75993

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