Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes."
Plain-English summary
Lusys Laboratories, Inc. is recalling 80 units of the Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette) test kits, Catalog No. I-102, Lot No. 11192014B. The recall is being conducted to stop and prevent further use of these devices. The affected products were distributed worldwide, including in the United States (specifically California), Canada, Sierra Leone, and Denmark.
The recall is necessary because the Ebola Virus One-Step Test Kits have not yet been cleared, approved, or authorized by the FDA for diagnostic purposes. The agency has not validated these devices for their intended use in diagnosing Ebola virus infection.
Consumers and healthcare providers who possess these test kits should stop using them immediately. The recall is limited to the specific lot number and catalog number identified in this notice.
The recalled product
- Product
- Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
- Manufacturer
- Lusys Laboratories, Inc.
- Affected units
- 80
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. 11192014B
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
- SevereLusys Laboratories 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
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
Similar recalls
- SevereLuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
- HighI.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation
FDA (Devices) · 2022-06-08
- HighSwab Drug Products Recalled Due to Manufacturing Validation Uncertainty
FDA (Devices) · 2022-06-08
- SevereOraSure Recalls OraQuick Ebola Rapid Antigen Test Due to Stability Failures
FDA (Devices) · 2016-08-24
- SevereLuscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
- ModerateEpigenomics Recalls Epi proColon Plasma Quick Kit Due to Invalid Test Runs
FDA (Devices) · 2018-03-28