SARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval
North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity score of 4. While no illnesses or injuries have been reported, the unauthorized distribution of diagnostic test kits without FDA approval poses a regulatory risk and could result in inaccurate test results affecting patient care decisions.
Plain-English summary
North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits packaged under multiple brand names including Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, and SML Brand BT Antigen Test Kit LDT. The recall involves approximately 122,366 units from lot FLUSA 1020-1, batches 8, 10, and 12.
These test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from the FDA. Because the kits lack FDA clearance, their performance characteristics have not been validated, creating a risk of inaccurate test results.
The affected products were distributed nationwide in Florida, Louisiana, Nevada, California, Colorado, Arizona, Connecticut, Ohio, Illinois, New York, Washington DC, Maryland, and Pennsylvania. International distribution also occurred in Zambia, Austria, Canada, United Arab Emirates, and Bangladesh.
Consumers who have these test kits should stop using them immediately. The FDA recommends using only FDA-authorized or cleared COVID-19 rapid antigen tests for accurate results.
The recalled product
- 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
- Manufacturer
- North American Diagnostics
- Hazard
- unapproved-device
- diagnostic-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: FLUSA 1020-1
- Batches 8
- 10
- and 12
Distribution
Distributed nationwide across the United States.
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