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Mas™ omni-cardio™

Official notice

16 Oct 2025

Last checked

16 Oct 2025

Medium riskHealth Canada

An official Health Canada notice concerns Mas™ omni-cardio™. Microgenics initiated recall of MAS Omni•CARDIO liquid assayed integrated cardiac control due to reported complaints of vial-to-vial variability when using the control with high sensitivity troponin I assays only (but not with standard/regular troponin I assays). No other analytes are reported to be showing variability between vials. This issue could result in a delay in reporting patient results. If the variability of the material exceeds your lab's specification, dispose of the material. Published 2025-10-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78304

Official notice

2025-10-16

The hazard

Microgenics initiated recall of MAS Omni•CARDIO liquid assayed integrated cardiac control due to reported complaints of vial-to-vial variability when using the control with high sensitivity troponin I assays only (but not with standard/regular troponin I assays). No other analytes are reported to be showing variability between vials. This issue could result in a delay in reporting patient results. If the variability of the material exceeds your lab's specification, dispose of the material.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

78304

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Affected products

Product 1

Affected products - MAS™ Omni-CARDIO™, Lot or serial number - OCRD2704U, Model or catalogue number - OCRD-SP

Product 2

Affected products - MAS™ Omni-CARDIO™, Lot or serial number - OCRD2704M, Model or catalogue number - OCRD-101

Product 3

Affected products - MAS™ Omni-CARDIO™, Lot or serial number - OCRD27043, Model or catalogue number - OCRD-303

Product 4

Affected products - MAS™ Omni-CARDIO™, Lot or serial number - OCRD27041, Model or catalogue number - OCRD-UL

Product 5

Affected products - MAS™ Omni-CARDIO™, Lot or serial number - OCRD2704S, Model or catalogue number - OCRD-MP

Product 6

Affected products - MAS™ Omni-CARDIO™, Lot or serial number - OCRD2704L, Model or catalogue number - OCRD-202

Product 7

Affected products - MAS™ Omni-CARDIO™, Lot or serial number - OCRD27042, Model or catalogue number - OCRD-L

Risk / hazard

Microgenics initiated recall of MAS Omni•CARDIO liquid assayed integrated cardiac control due to reported complaints of vial-to-vial variability when using the control with high sensitivity troponin I assays only (but not with standard/regular troponin I assays). No other analytes are reported to be showing variability between vials. This issue could result in a delay in reporting patient results. If the variability of the material exceeds your lab's specification, dispose of the material.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Microgenics, Mas™ Omni-cardio™.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

78304

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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