SARS-CoV-2 Antigen Rapid Test Kits Recalled for Lack of FDA Authorization
Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.
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 medical device recall, which mandates a minimum severity score of 4 per the rules. No illnesses or injuries have been reported, preventing escalation to Critical (score 5).
Plain-English summary
Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed under the brand names Skippack Medical Lab and DiagnosUS. The recalled products are labeled as SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT in green and white boxes, or as SARS-CoV-2 Antigen Development in white boxes marked MADE IN USA ORAL SWAB TESTING.
The products were distributed without FDA market approval, clearance, or Emergency Use Authorization. Because these test kits have not undergone FDA review, their safety and effectiveness have not been verified.
The recalled products were distributed nationwide in California and Texas. Affected lot numbers are: UL-AG-2111-01-Q, UL-AG-2111-02-Q, UL-AG-2110-05-Q, UL-AG-2112-02-Q, UL-AG-2110-03-Q, and UL-AG-2110-04-Q (Model Number 550-10).
Consumers in possession of these test kits should stop using them and contact Universal Meditech Inc. for a refund or replacement with an FDA-authorized product.
The recalled product
- Product
- 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 TES
- Manufacturer
- Universal Meditech Inc.
- Hazard
- unvalidated-device
- unauthorized-distribution
Distribution
Distributed nationwide across the United States.
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