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U.S. Department of Health and Human Services

Class 1 Device Recall STANDARD Q COVID19 Ag Home Test

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 Class 1 Device Recall STANDARD Q COVID19 Ag Home Testsee related information
Date Initiated by FirmJanuary 31, 2022
Create DateMarch 16, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0719-2022
Recall Event ID 89527
Product Classification Coronavirus antigen detection test system. - Product Code QKP
ProductSTANDARD 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.
Code Information REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)
Recalling Firm/
Manufacturer		 SD Biosensor, Inc.
1556 Beon-Gil, Yeongtong
C4th & 5th Floor Digital Empire Bldg, 16, Deogyeong-Daero
Suwon Korea (the Republic of)
For Additional Information ContactPriscilla Chung
714-202-5789
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 info@lkconsultinggroup.com Korea Contact - Tel: 070-4498-0742
Quantity in Commerce~400,000 kits
DistributionU.S. Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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