FDANovember 28, 2022device
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
What to do
FDA enforcement status: Ongoing
Brands named
universal meditechuniversal
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCSamson International Recalls Bellevue and Oaklynn Canopy Bed Frames Due to Impact and Injury Hazards2026-04-02
- FDAHealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips2023-05-22
- FDAHealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP2023-05-22
- FDAOne Step Ovulation Test REF 200-012023-05-22
- FDALem Fertility LH Ovulation Test (Strip) REF 200-072023-05-22
- FDAOne Step Pregnancy Test REF 100-012023-05-22
- FDADiagnosUS Ovulation Predictor Midstream REF 200-172023-05-22
- FDADeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-132023-05-22
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →