Lower riskMedical device recall · FDA · Published October 1, 2025
Thermo Scientific MAS Omni CARDIO Recall: Vial Variability Risk in Troponin I Assays
Thermo Scientific recalls specific models of cardiac control devices due to vial-to-vial variability in high-sensitivity Troponin I assays, potentially delaying patient results.
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.
Take action
Contact the company
📍Recalling firmMicrogenics Corporation46500 Kato Rd · Fremont, CA 94538-7310
“Thermo Scientific MAS Omni CARDIO Recall: Vial Variability Risk in Troponin I Assays.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51138-thermo-scientific-mas-omni-cardio-recall-vial-variability-risk-in. Based on FDA recall #Z-0415-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0415-2026%22&limit=1).
The FDA announced on Oct. 1, 2025, that Microgenics Corporation is recalling Thermo Scientific MAS Omni CARDIO liquid assayed integrated cardiac control due to vial-to-vial variability that may delay patient results for high sensitivity Troponin I assays. The agency issued recall number Z-0415-2026 for the Class II voluntary recall.
How to tell if you have it
Brand: Thermo Scientific
Product: MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control
Lot Numbers: OCRD2704U, OCRD2704L, OCRD27041, OCRD27042, OCRD27043, OCRD2704S, OCRD2704M
Expiration Dates: 2027-04-30
Units Affected: 4462
The hazard
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 a delay in patient results for hs Troponin I assays.
Context
GovInfoNow's records show Microgenics Corporation has one other recall on record since Jan. 20, 2022, involving QMS Tacrolimus Calibrators that may cause over-quantitation in patient results. Other recent recalls of similar products include Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), Copan Italia DTT Liquid Reagent Recall (Oct. 29, 2025), and Covidien Mon-a-Therm Stethoscope Recall (April 23, 2026).
How to tell if you have this one
Check for model numbers OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, or OCRD-UL on the device. The product was sold with specific expiration dates in 2027.
Brand
Thermo Scientific
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number on the device to confirm if it is one of the recalled models: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, or OCRD-UL.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, Georgia, Idaho, Illinois, Louisiana, New Hampshire, New York, Oklahoma, Texas, Utah, Wisconsin.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0415-2026 (October 1, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0415-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.