The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0716-2022·Announced 2022-03-16

LuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.

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: FDA Class I recall of an unauthorized medical device. The rubric mandates a minimum score of 4 for all FDA Class I recalls. No illnesses or injuries have been reported, but the product was distributed without required FDA authorization, clearance, or approval.

Plain-English summary

Lusys Laboratories, Inc. is recalling the LuSys 2nd Generation COVID-19 Viral Antigen Test (saliva test), distributed as 14,745 kits. The test kits lack authorization, clearance, or approval from the U.S. Food and Drug Administration (FDA) and do not have an Emergency Use Authorization (EUA).

Because these test kits were not authorized, cleared, or approved for marketing and distribution in the United States, they lack the validation required to ensure their safety and effectiveness. Unauthorized medical devices may not have undergone adequate testing or quality control.

The kits were distributed worldwide, including in the U.S. states of California, North Carolina, Nevada, Ohio, Tennessee, and Texas, as well as Canada, China, and Mexico. All lot numbers of the product are affected by this recall.

Consumers and healthcare providers who have received these test kits should stop using them immediately and discontinue distribution. Contact Lusys Laboratories, Inc. with questions or to report possession of the kits.

The recalled product

Product
LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
Manufacturer
Lusys Laboratories, Inc.
Category
Medical Device — Diagnostic Test
Hazard
Affected units
14,745

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 →

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