Recalls · Brand

Lusys Laboratories, Inc. recalls

Every recall we track for Lusys Laboratories, Inc. — 3 in all, all from 2022 — plus the complaints and injury reports the public filed about them.

3recalls

Recalls per year, by danger level

Recalls from Lusys Laboratories, Inc. peaked in 2022 (3); 3 since 2017.

All FDA recall records for Lusys Laboratories, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Lusys Laboratories, Inc., by danger level
Year	Lower risk	Total
2017	0	0
2018	0	0
2019	0	0
2020	0	0
2021	0	0
2022	3	3
2023	0	0
2024	0	0
2025	0	0
2026 (to date)	0	0

What to do if you have a recalled Lusys Laboratories, Inc. product

Match the model, catalog or lot number on your device to the recall.
Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
Report problems to FDA MedWatch.

See this week’s new recalls.

All Lusys Laboratories, Inc. recalls

1 shown

Lower riskMedical device
Lusys Laboratories, Inc. recalls Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Lusys recalls its 2nd Gen COVID-19 antigen test kits as they lack U.S. FDA authorization. These kits may not be reliable for detecting the virus in the U.S. market.
LusysJan 13, 2022

Lusys Laboratories, Inc. recall questions

How many recalls has Lusys Laboratories, Inc. had?

3 recalls from Lusys Laboratories, Inc. are on record with U.S. safety agencies, from 2022.

What is the most recent Lusys Laboratories, Inc. recall?

Lusys Laboratories, Inc. recalls Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test), dated Jan 13, 2022. Every Lusys Laboratories, Inc. recall is listed on this page, newest first.

What should I do if I have a recalled Lusys Laboratories, Inc. product?

Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.

How do I get alerts for new Lusys Laboratories, Inc. recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.