SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML L
Summary
The FDA issued a Class I for SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Ra by North American Diagnostics. Reason: Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing appro.
Details
Source
Device Recall
External ID
Z-1401-2022
Action Date
2022-08-10
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot: FLUSA 1020-1, Batches 8, 10, and 12
Quantity Affected: 122,366 units
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, LA, NV, CA, CO, AZ, CT, OH. IL, NY, DC, MD, PA, and the countries of Zambia, Austria, Canada, UAE, Bangladesh.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-15
Company
Holly Hill, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (North American Diagnostics) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does North American Diagnostics have FDA actions?
This is the only FDA action we have on record for North American Diagnostics in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1401-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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