Medical Device Recall: 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 Diagn
Microgenics Corporation · October 1, 2025
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.
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
Distribution
Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI, IL, LA, AR, TX, UT, GA, ID and the countries of MEX, CAN, KOR, MYS, DEU, GBR, BRA, JAP, HKG, NZL, AUS.
States Affected
NATIONWIDE
Quantity Affected
4462
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0415-2026
Status: ongoing
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