Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic medical device that is not FDA-cleared, approved, or authorized. Per the rubric, this is classified as a risk-of-harm product where injury has not yet been reported, corresponding to a score of 3 (High).
Plain-English summary
Lusys Laboratories, Inc. is recalling 40 units of the Ebola Virus One Step Test Kits (Catalog No. I-124). The recall is being conducted to stop and prevent further use of these devices.
The reason for the recall is that 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) and internationally to Canada, Sierra Leone, and Denmark.
Consumers and healthcare providers who possess these test kits should stop using them immediately. The recall is intended to prevent the use of unapproved diagnostic devices.
The recalled product
- Product
- Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
- Manufacturer
- Lusys Laboratories, Inc.
- Hazard
- Affected units
- 40
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)
- n/a
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
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