Reported Feb 8, 2023 · Ongoing
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green…
Universal Meditech Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Universal Meditech Inc. · 1320 E Fortune Avenue, Suite 102 · Fresno, CA · 93725
Is this the product you have?
- Products are labeled asSkippack 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
- Lot codes and dates
- Model Number550-10
- UDI CodeNone
- Lot NumbersUL-AG-2111-01-Q UL-AG-2111-02-Q UL-AG-2110-05-Q UL-AG-2112-02-Q UL-AG-2110-03-Q UL-AG-2110-04-Q
- Amount recalled
- 56,300 kits
Where it was sold
Why it was recalled
Stop using this product now
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Using this product could cause serious injury, illness or death — stop using it now.
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