Health product recall

Mas Omni Cardio

Last updated

Summary

Product
Mas Omni Cardio
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalog number
Mas Omni Cardio OCRD2503S OCRD2503L OCRD2503U OCRD-SP OCRD-UL OCRD-L

Issue

Manufacturer initiated recall notifying users of lot-specific open vial stability claim reduction = IFU correction to affected lots. Open vial stability for troponin I present in OCRD-UL, OCRD-I and OCRD-SP does not meet the 15 day claim in IFU. Analysis has demonstrated that the analyte is stable for 5 days once the vial is opened. Informing cosignees prior to use via each unit including a product bulletin and labelling on orange paper with corrected open vial stability.

Recall start date: September 29, 2022

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
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72016