medical Class I Updated 2022-08-10

North American Diagnostics recalls SARS CoV 2 rapid antigen test kits packaged under the follow

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: FLUSA 1020-1, Batches 8, 10, and 12
View official government recall

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