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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 2,055
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
Related recalls
Same hazard · unauthorized distribution
See all →- ModerateUric Acid in vitro diagnostic test distributed without FDA clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step UTI in vitro diagnostic test recalled for missing FDA approval
FDA (Devices) · 2026-05-13
- ModerateQUCARE Total Cholesterol in vitro Diagnostic Test Recalled
FDA (Devices) · 2026-05-13
- ModeratePluslife SARS-CoV-2 Card Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2025-06-25
- HighStreptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
FDA (Devices) · 2024-06-19
Similar recalls
- SevereCOVID-19 Rapid Antigen Test Kits Recalled for Unauthorized Distribution
FDA (Devices) · 2022-05-18
- SevereCOVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization
FDA (Devices) · 2022-05-11
- SevereSARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval
FDA (Devices) · 2022-08-10
- SevereCOVID-19 Antigen Test Kit Distributed Without FDA Authorization or Clearance
FDA (Devices) · 2022-05-18
- SevereCOVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
FDA (Devices) · 2022-02-09
- SevereLuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16