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Health Canada Medical devices

Vitros Chemistry Products System - CKMB Slides (Creatine Kinase Mb)

Issued December 8, 2021
Issue
The affected vitros CKMB slides coating does not adequately inhibit CK-mm up to a total CK more than 1000 u/L. Therefore, samples with a total CK value less than 1000 u/L may exhibit falsely elevated vitros CKMB slides results. Recall start date: Nov 30, 2021
Hazard description
Inaccurate test or measurement results
Product
Product name
Vitros Chemistry Products System - CKMB Slides (Creatine Kinase Mb)
Reference
ID
RA-63695