Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Numbe...
FDA Recall #Z-0415-2026 — Class II — October 1, 2025
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.
Recalling Firm
Microgenics Corporation — Fremont, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4462
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.
Code Information
OCRD-UL: UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30; OCRD-L: UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30; OCRD-101: UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30; OCRD-202: UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30; OCRD-303: UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30; OCRD-SP: UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30; OCRD-MP: UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated