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MAS Omni-CARDIO Liquid Assayed Integrated Cardiac ControlRecalls & reported problems across all models

Microgenics Corporation · 7 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names at least one MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
1

We found 7 models of MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control by Microgenics Corporation in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Oct 1, 2025Class IIOpen, Classified

    The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

    Z-0415-2026 · Root cause: Nonconforming Material/Component · names 7 of these models · Recall details · FDA record ↗

MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page