FDA-Device2022-10-19Class IMISBRANDING
SDI Labs COVID-19 Ag Rapid Test (Cat# CO-02) recalled—distributed without FDA authorization
FALSE CLAIMSCA
Stop using SDI Labs COVID-19 rapid tests
SDI Labs COVID-19 Ag Rapid Test kits (catalog number CO-02) were sold in the United States without FDA approval or emergency authorization. The FDA has determined these tests should not have been distributed. Approximately 620,000 tests are affected.
- Stop using this test kit immediately
- Do not rely on results from this test for medical decisions
- Contact your doctor or pharmacy if you used this test and made health decisions based on the result
- Return unused kits to the place of purchase if possible
Hazard
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Sold states
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Affected count
620,000 tests
Manufactured in
No 9 Changyang Rd West, N/A, Changzhou, N/A, China
Products
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief