Health product recall

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

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

FebriDx

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

RPS-FDX-CA

Companies
Manufacturer
RAPID PATHOGEN SCREENING, INC
7227 DELAINEY COURT
SARASOTA
34240
Florida
UNITED STATES