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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 17,000
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
Part of a larger recall action
This product is one of 2 recalled by Woodside Acquisitions Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Woodside Acquisitions Inc.
See all →- SevereCOVID-19 Rapid Antigen Test Kits Recalled for Unauthorized Distribution
FDA (Devices) · 2022-05-18
Same hazard · unapproved device
See all →- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateOne Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13
Similar recalls
- SevereCOVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization
FDA (Devices) · 2022-05-11
- HighFDA Recalls Unauthorized COVID-19 Antigen Rapid Test Kits
FDA (Devices) · 2022-05-18
- SevereSARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval
FDA (Devices) · 2022-08-10
- SevereCOVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
FDA (Devices) · 2022-02-09
- SevereJiangsu Well Biotech COVID-19 test kits distributed without FDA authorization
FDA (Devices) · 2022-10-19
- ModerateSky Medical SARS-CoV-2 Rapid Test Kits Recalled for Lack of Emergency Use Authorization
FDA (Devices) · 2021-02-24