FDAClass IMarch 23, 2022

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag recall

STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2…

Why was STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag recalled?

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)

Product
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2…
Recalling firm
SD Biosensor, Inc.
Quantity
~400,000 kits
Distribution
U.S. Nationwide Distribution
Recall date
March 23, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls