Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.
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 source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Lusys Laboratories, Inc. is recalling 40 units of the Ebola Virus One Step Test Kits, Catalog No. I-103, Lot No. 12012014A. The recall is being conducted to stop and prevent further use of these devices.
The FDA has determined that the Ebola Virus One-Step Test Kits have not yet been cleared, approved, or authorized by the FDA for diagnostics purposes. The agency has classified this recall as Class I.
The affected units were distributed worldwide, including in the United States (specifically California), Canada, Sierra Leone, and Denmark. Consumers and healthcare providers should stop using these test kits immediately.
The recalled product
- Product
- Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 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)
- Lot No. 12012014A
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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