Reported Aug 10, 2022 · Ongoing
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML…
North American Diagnostics
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: North American Diagnostics · 618 Ridgewood Ave · Holly Hill, FL · 32117-3604
Is this the product you have?
- SARS CoV 2 rapid antigen test kits
- packaged under the following brandsOral 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
- Lot codes and dates
- Lot
FLUSA 1020-1Batches 810and 12
- Lot
- Amount recalled
- 122,366 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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