FDA-Device2022-08-10Class I
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
North American Diagnostics
Hazard
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Sold states
Worldwide distribution - US Nationwide distribution in the states of FL, LA, NV, CA, CO, AZ, CT, OH. IL, NY, DC, MD, PA, and the countries of Zambia, Austria, Canada, UAE, Bangladesh.
Affected count
122,366 units
Manufactured in
618 Ridgewood Ave, N/A, Holly Hill, FL, United States
Products
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1401-2022Don't want to check this manually?
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