Lusys Laboratories, Inc.
Complete recall history across all FDA and CPSC categories — 11 total recalls
Lusys Laboratories, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (11)
FDA medical device enforcement actions by Lusys Laboratories, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 13, 2022 | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibod... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are n... | Class I |
| Jan 13, 2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Ca... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are n... | Class I |
| Jan 13, 2022 | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mu... | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are n... | Class I |
| Mar 13, 2015 | Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus ... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
| Mar 13, 2015 | Ebola Accessories assembled, self-contained package, Catalog No. I-104 vir... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
| Mar 13, 2015 | Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials P... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
| Mar 13, 2015 | Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. ... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
| Mar 13, 2015 | Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Mater... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
| Mar 13, 2015 | Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
| Mar 13, 2015 | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. T... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
| Mar 13, 2015 | Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials P... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and pr... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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