The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0717-2022·Announced 2022-03-16

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units
90,849

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Lusys Laboratories, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Lusys Laboratories, Inc.

See all →

Same hazard · unauthorized device

See all →

Similar recalls