Unauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval
SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies. Although no illnesses or injuries have been reported, unapproved medical devices pose regulatory and potential safety risks. Per rubric, FDA Class I recalls must score at least 4 (Severe).
Plain-English summary
The STANDARD Q COVID-19 Ag Home Test is a rapid diagnostic immunoassay designed to detect SARS-CoV-2 nucleocapsid antigen in human nasal samples. Approximately 400,000 units (Lot 59628J1T1) manufactured by SD Biosensor, Inc., were imported and distributed throughout the United States.
These test kits were not approved, cleared, or authorized by the U.S. Food and Drug Administration for distribution in the United States. Their unapproved status means they have not undergone the FDA's required evaluation and authorization processes for medical devices, leaving their performance and safety unvalidated.
If you have one of these test kits, do not use it. Consult with a healthcare provider or contact the FDA for guidance regarding proper handling and disposal. For additional information, contact the FDA or your local health department.
The recalled product
- 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 nucleocapsid antigen present in human nasal sample.
- Manufacturer
- SD Biosensor, Inc.
- Affected units
- 400,000
Distribution
Distributed nationwide across the United States.
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