MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control recallZ-0415-2026 · Microgenics Corporation · initiated Oct 1, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microgenics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
ThermoFisher Scientific issued an URGENT -MEDICAL DEVICE RECALL notice to its consignees on 10/02/2025 via email. The notice explained the issue, risk to health, and requested the following: "ACTIONS TO BE TAKEN BY A USER 1. If you are a user of the High sensitivity Troponin I Assay, determine if you have inventory of the affected lots of MAS Omni"CARDIO" control as listed in Table 1. As stated in the instructions for use, instrument values provided are specific to this lot of control only and are intended to assist the laboratory in establishing its own means and ranges. 2. You may continue to use controls that meet your laboratory s performance requirements. 3. If the variability of the material exceeds your laboratory s specification, dispose of the material in accordance with local, regional, and national regulations. After disposing of the material, contact [email protected] for a credit. 4. Customers using the affected product with standard/ regular Troponin I assays, can continue to use the product as long as it meets their laboratory s specification and continue monitoring performance of Troponin I in MAS Omni"CARDIO" control. 5. This recall notice needs to be passed to anyone within your organization or any organization where the potentially affected lots have been transferred. 6. Retain a copy of this letter for your laboratory records. 7. Please complete the Recall Response Form attached to this Notification within 10 days of the date of this letter and return to Thermo Fisher as instructed in the form to E-mail:[email protected] 8. If you have any additional questions regarding this Recall Notice, contact Thermo Fisher Scientific Technical Support at toll free 1-800-232-3342 (USA and Canada only) or 510-979-5000 (International), Option 2, then option 3 or by email: [email protected]." "ACTIONS TO BE TAKEN BY A DISTRIBUTOR 1. Please notify your customers of this Recall Notice using this recall notice and request t
Recall details
- Recall number
- Z-0415-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 1, 2025
- Posted by the FDA
- Oct 30, 2025
- Recalling firm
- Microgenics Corporation
- Quantity
- 4462
- Product code
- JJY
- 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.
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
Code information (models, lots, serial numbers)
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.
Devices named in this recall
7 devices in the FDA device registry whose identifier appears in the recall's code information.
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-ULMicrogenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-LMicrogenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-101Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-202Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-303Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-SPMicrogenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-MPMicrogenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page