FebriDx (2020-12-21)

Starting date:

December 21, 2020

Posting date:

December 31, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74693

Last updated:
2020-12-31

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  Reason
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  Affected products

Affected Products 

FebriDx

Reason

Notification to inform customers that Febridx is authorized for use to identify and differentiate viral from bacterial acute respiratory infection; its use for the specific diagnosis of COVID-19 is not authorized by Health Canada.

Affected products