Recall Z-0415-2026— Microgenics Corporation
Class II · Ongoing
Class II FDA medical device recall by Microgenics Corporation, initiated 2025-10-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Microgenics Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-01
- Firm location
- Fremont, CA, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.