Luscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.
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 recall, which requires a minimum severity score of 4 per the severity rubric. Although no illnesses or injuries are reported, unauthorized medical devices have not undergone FDA review and approval, creating potential risk of diagnostic inaccuracy.
Plain-English summary
Lusys Laboratories, Inc. is recalling Luscient Diagnostics 2nd Generation COVID-19 Viral Antigen Test kits (nasal swab). All lot numbers of this product are affected, totaling 90,849 kits distributed worldwide.
The kits are being recalled because they were not authorized, cleared, or approved for marketing and distribution in the United States. These test kits do not have an Emergency Use Authorization (EUA) from the FDA, which is required for COVID-19 diagnostic devices.
The recalled kits were distributed nationwide in California, North Carolina, Nevada, Ohio, Tennessee, and Texas, as well as internationally to Canada, China, and Mexico. Consumers, healthcare providers, and retailers who have received these kits are affected.
Consumers and healthcare providers should stop using this product immediately and dispose of it safely. Anyone who used these test kits and has questions about their test results should consult with a healthcare provider.
The recalled product
- Product
- Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
- Manufacturer
- Lusys Laboratories, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- unauthorized-device
- diagnostic-inaccuracy
Distribution
Distributed nationwide across the United States.
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