Reported Nov 5, 2025 · Ongoing

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101,…

Microgenics Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microgenics Corporation · 46500 Kato Rd · Fremont, CA · 94538-7310

Is this the product you have?

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control
Model/Catalog NumberOCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL
Product DescriptionIn Vitro Diagnostic external control

Lot codes and dates: 7 of 7 products
Products covered by this recall
# Barcodes Product as published
1 00884883011946 UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30
2 00884883011953 OCRD-L: UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30
3 00884883011960 OCRD-101: UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30
4 00884883011977 OCRD-202: UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30
5 00884883011984 OCRD-303: UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30
6 00884883011991 OCRD-SP: UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30
7 00884883012004 OCRD-MP: UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30.
Amount recalled: 4462

Where it was sold

Nationwide
AL
OK
NH
NY
WI
IL
LA
AR
TX
UT
GA
ID

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.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Medical device recalls

Other recalls from Microgenics Corporation

QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3… Jul 6, 2022
Thermo Scientific QMS Everolimus Assay Oct 12, 2016
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate… Oct 5, 2016
MAS CardioImmune XL Cardiac Marker Control Dec 10, 2014
MAS Omni Immune Controls Jul 2, 2014
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is… Jul 3, 2013

7 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`00884883011946`	UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30
2	`00884883011953`	OCRD-L: UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30
3	`00884883011960`	OCRD-101: UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30
4	`00884883011977`	OCRD-202: UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30
5	`00884883011984`	OCRD-303: UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30
6	`00884883011991`	OCRD-SP: UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30
7	`00884883012004`	OCRD-MP: UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30.