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FDAJune 15, 2022device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

north american diagnosticsnorthnorth american

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear