COVID-19 Antigen Test Kit Distributed Without FDA Authorization or Clearance
The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.
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. Per the severity rubric, Class I recalls never score below 4. The tests were distributed without FDA clearance or authorization, creating a risk that inaccurate results could lead to serious health consequences.
Plain-English summary
Woodside Acquisitions Inc. is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)—a COVID-19 rapid antigen test—that were distributed in Alabama and Georgia. All lots of the product are affected.
The firm distributed these tests without obtaining FDA clearance or authorization for marketing or distribution in the United States. Unauthorized medical devices may not meet FDA safety and effectiveness standards and could provide inaccurate results.
Consumers who purchased or received these test kits in Alabama or Georgia may have been affected. Those with these kits should not rely on test results for clinical decision-making.
If you have these test kits, discontinue use and contact your healthcare provider with questions about your COVID-19 status or authorized testing options.
The recalled product
- Product
- Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
- Manufacturer
- Woodside Acquisitions Inc.
- Hazard
- unapproved-device
- unauthorized-distribution
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)
- All lots
Distribution
Distributed in 2 states:
- AL
- GA
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