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Open, Classified

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 nucleocapsid antigen present in human nasal sample.

FDA Recall Z-0719-2022 · Posted None

Recalling FirmSD Biosensor, Inc.
Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2022-01-31
Product Quantity~400,000 kits

Reason for Recall

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.

Firm Action

On 02/02/2022, SD Biosensor, Inc. a global in-vitro diagnostic company notified U.S Food and Drug Administration (US FDA) that the firm was voluntarily recalling its STANDARD Q COVID-19 Ag Home Test kits due to confirmed reports that the test kits were illegally imported into the U.S. The Home Test kits are not approved or authorized by the US FDA for sale in the U.S. US FDA was informed that the SD Biosensor, Inc. sent a "Cease and Desist Letter Related to STANDARD Q COVID-19 Ag Test in the USA" demanding that the distributor take immediate action to cease and desist from all further sale or activities related to the product for use in the USA. For questions/assistance: U.S. Contact - Tel: +1-714-202-5789 or email [email protected] Korea Contact - Tel: 070-4498-0742

Root Cause

Under Investigation by firm

Distribution Pattern

U.S. Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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