|
|
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
|
|
|
TOPIC: STANDARD Q COVID-19 Ag Home Test by SD BIOSENSOR: Recall - Due to Test Kits Being Illegally Imported Into The United States
AUDIENCE: Consumer, Health Professional
ISSUE: SD Biosensor is recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the FDA for distribution or use in the United States. There is no known distribution of these tests directly to consumers.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
RECOMMENDATIONS:
- In the unlikely event that consumers in the United States encounter the ‘STANDARD Q COVID-19 Ag Home Test’, they are encouraged to discard and avoid any use of the test, as it has not been authorized, cleared or approved by the FDA for use in COVID-19 testing and diagnosis in the United States.
- Consumers that have used the test are strongly encouraged to consider retesting with an FDA authorized or cleared test.
|
|
|
Health professionals and patients consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
-
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
|
|
|
|
