The Recall Desk
HighFDA (Devices)·Z-0415-2026·Announced 2025-11-05

Cardiac control material recalled over vial to vial troponin variability

Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the defect may delay high sensitivity Troponin I results, and no injuries are reported.

Plain-English summary

Thermo Scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, an in vitro diagnostic external control, is being recalled across catalog numbers OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP and OCRD-UL.

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. The firm states this defect may lead to a delay in patient results for hs Troponin I assays.

The recall covers 4,462 units, including lot OCRD2704U (expiring 30 April 2027), distributed worldwide including in Alabama, Oklahoma, New Hampshire, New York, Wisconsin, Illinois, Louisiana, Arkansas, Texas, Utah, Georgia and Idaho. The FDA has classified the action as Class II.

High sensitivity Troponin I is used in the assessment of suspected heart attack, so a delay in results has clinical weight. Laboratories holding affected lots should follow the firm's instructions.

The recalled product

Product
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
Manufacturer
Microgenics Corporation
Category
Medical Device — Diagnostic control
Hazard
  • assay-variability
  • delayed-results
  • cardiac-diagnostics
  • in-vitro-diagnostic

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • OCRD-UL: UDI/DI 00884883011946
  • Lot Number OCRD2704U
  • Exp 2027-04-30
  • OCRD-L: UDI/DI 00884883011953
  • Lot Number OCRD2704L
  • OCRD-101: UDI/DI 00884883011960
  • Lot Number OCRD27041
  • OCRD-202: UDI/DI 00884883011977
  • Lot Number OCRD27042
  • OCRD-303: UDI/DI 00884883011984
  • Lot Number OCRD27043
  • OCRD-SP: UDI/DI 00884883011991
  • Lot Number OCRD2704S
  • OCRD-MP: UDI/DI 00884883012004
  • Lot Number OCRD2704M
  • Exp 2027-04-30.

Distribution

Distributed nationwide across the United States.

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