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Microgenics recalls
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Microgenics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-11-05FDA-DeviceClass IIThermo 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
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.
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