North American Diagnostics

1 recall •

• Categories: Diagnostic Equipment

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

Class I - Dangerous

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.

Jun 15, 2022 Diagnostic Equipment Nationwide View Details →