Product Wiki · Recalls · Health Canada — Medical Devices

Creatine kinase-MB (CK-MB) (2018-08-05) — recall 58753

Health Canada — Medical Devices · Canada · 2019-01-11 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58753
Date of alert
2019-01-11
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Following internal investigation of customer complaints, the manufacturer confirmed that an increased absolute absorbance for both calibration standards and reduced control recoveries could occur for the product Creatine Kinase-MB (#05168562190) lot # 31195601 used on cobas c 701/702 module.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/creatine-kinase-mb-ck-mb-2018-

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