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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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