Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a reasonable probability of serious adverse health consequences. However, the specific hazard is the use of an uncleared diagnostic device rather than a direct physical injury or contamination event, and no injuries or illnesses are reported in the source text. This aligns with a Moderate severity for a regulatory compliance recall of a diagnostic tool.
Plain-English summary
Lusys Laboratories, Inc. is recalling 20 units of Ebola Virus One Step Test Kits (Catalog No. I-104, Lot No. DEI007963). The recall is being conducted to stop and prevent further use of these devices.
The recall is necessary because the Ebola Virus One-Step Test Kits have not yet been cleared, approved, or authorized by the FDA for diagnostics purposes. The affected units were distributed worldwide, including in the United States (specifically California), Canada, Sierra Leone, and Denmark.
Consumers and healthcare providers who possess these specific test kits should stop using them immediately. The recall is limited to the specific lot number and catalog number identified in the source text.
The recalled product
- Product
- Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
- Manufacturer
- Lusys Laboratories, Inc.
- Hazard
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. DEI007963
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 8 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 8 products in this recall →Related recalls
Same manufacturer · Lusys Laboratories, Inc.
See all →- SevereLuscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
- 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
- ModerateLusys Laboratories Recalls Uncleared Ebola Virus One Step Test Kits
FDA (Devices) · 2015-04-15
Same hazard · uncleared device
See all →- SevereMedline angiography and catheter kits subject to rescinded regulatory clearances
FDA (Devices) · 2026-04-29
- ModerateJewel Precision Sterilization Container System Recalled for FDA Non-Clearance
FDA (Devices) · 2025-07-02
- HighOtological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
FDA (Devices) · 2025-01-29
- ModerateOtological Ventilation Tubes Recalled for Lack of FDA 510(k) Clearance
FDA (Devices) · 2025-01-29
- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31