Sofia SARS Antigen FIA (2021-04-23)

Starting date:

April 23, 2021

Posting date:

May 13, 2021

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-75573

Last updated:
2021-05-13

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  Reason
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  Affected products

Affected Products

Sofia SARS Antigen FIA

Reason

Quidel has distributed advertising information with new unapproved claims regarding detection of variants of SARS-CoV-2 virus.  The Sofia SARS Antigen FIA device continues to perform as stated "… for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 …"

Affected products