The Recall Desk
HighFDA (Devices)·Z-1050-2022·Announced 2022-05-18

FDA Recalls Unauthorized COVID-19 Antigen Rapid Test Kits

USA Medical, LLC distributed 2055 COVID-19 antigen test kits nationwide. The tests did not receive FDA Emergency Use Authorization nor were they cleared or approved for commercial distribution.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall of an unauthorized diagnostic device. While no illnesses or injuries have been reported, this addresses a risk-of-harm situation: unvalidated tests may provide inaccurate COVID-19 results, potentially leading to incorrect medical decisions.

Plain-English summary

USA Medical, LLC distributed 2055 COVID-19/SARS-CoV-2 antigen rapid test diagnostic kits across eight states: California, Florida, Indiana, Maryland, Missouri, New Jersey, Oklahoma, and Tennessee.

The tests were neither cleared, approved, nor authorized by the FDA for commercial distribution, and they did not receive Emergency Use Authorization.

If you obtained these test kits, you should be aware that they were not approved by the FDA for COVID-19 testing and lack regulatory clearance.

The recalled product

Product
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Manufacturer
USA Medical, LLC
Category
Medical Device — Diagnostic Test
Hazard
  • unauthorized-distribution
  • 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 (1)

  • Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None

Distribution

Distributed nationwide across the United States.

Related recalls

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