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Health Canada Medical devices

MAS™ Omni-CARDIO™

Issued October 16, 2025
Issue
Microgenics initiated recall of MAS Omni•CARDIO liquid assayed integrated cardiac control due to reported complaints of vial-to-vial variability when using the control with high sensitivity troponin I assays only (but not with standard/regular troponin I assays). No other analytes are reported to be showing variability between vials. This issue could result in a delay in reporting patient results. If the variability of the material exceeds your lab's specification, dispose of the material.
Hazard description
Performance
Product
Product name
MAS™ Omni-CARDIO™
Reference
ID
RA-78304