Microgenics Corporation: Device Recall
Recall #Z-0415-2026 · 10/01/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0415-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Microgenics Corporation
- Status
- Ongoing
- Date Initiated
- 10/01/2025
- Location
- Fremont, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4462
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 Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.