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
- Affected units
- 90,849
Distribution
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 →- SevereLuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
- SevereFDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization
FDA (Devices) · 2022-03-16
- ModerateLusys Recalls Uncleared Ebola Virus One Step Test Kits
FDA (Devices) · 2015-04-15
- SevereLusys Recalls Uncleared Ebola Virus One Step Test Kits
FDA (Devices) · 2015-04-15
- ModerateLusys Recalls Uncleared Ebola Virus One Step Test Kits
FDA (Devices) · 2015-04-15
Same hazard · unauthorized device
See all →- ModerateDVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization
FDA (Devices) · 2024-10-09
- HighRoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization
FDA (Devices) · 2023-10-18
- SevereCOVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization
FDA (Devices) · 2022-05-11
- SevereFDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
FDA (Devices) · 2022-02-16
- SevereLeccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution
FDA (Devices) · 2021-06-09