Health product recall

MAS™ Omni-CARDIO™

Last updated

Summary

Product
MAS™ Omni-CARDIO™
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

MAS™ Omni-CARDIO™

OCRD2704U

OCRD-SP

MAS™ Omni-CARDIO™

OCRD2704M

OCRD-101

MAS™ Omni-CARDIO™

OCRD27043

OCRD-303

MAS™ Omni-CARDIO™

OCRD27041

OCRD-UL

MAS™ Omni-CARDIO™

OCRD2704S

OCRD-MP

MAS™ Omni-CARDIO™

OCRD2704L

OCRD-202

MAS™ Omni-CARDIO™

OCRD27042

OCRD-L

Issue

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Microgenics Corporation

46500 Kato Road, Fremont, California, United States, 94538

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78304

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