Mas Omni Cardio
Brand(s)
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
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