Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Thermo scientific MAS Omni CARDIO Recalled by Microgenics Corporation Due to The firm received complaints from customers reporting vial-to-vial...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Microgenics Corporation directly.
Affected Products
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
Quantity: 4462
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Microgenics Corporation
Microgenics Corporation has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report