STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qual
Summary
The FDA issued a Class I for STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid by SD Biosensor, Inc.. Reason: 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..
Details
Source
Device Recall
External ID
Z-0719-2022
Action Date
2022-03-23
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: REF No. Q-NCOV-03G Catalog No.: 09COV130 Lot Number: 59628J1T1 (Potentially 59628J1T1/2)
Quantity Affected: ~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.
Distribution
U.S. Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-31
Company
Suwon, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SD Biosensor, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SD Biosensor, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SD Biosensor, Inc. have FDA actions?
SD Biosensor, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0719-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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