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Mas omni cardio
Official notice
14 Oct 2022
Last checked
14 Oct 2022
An official Health Canada notice concerns Mas omni cardio. 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 Published 2022-10-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72016
Official notice
2022-10-14
The hazard
The hazard
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
How to check if you're affected
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.
Lots
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Microgenics, Mas Omni Cardio.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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