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
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which the rubric defines as unlikely to cause adverse health consequences. The hazard is the use of an unauthorized diagnostic device rather than a direct physical injury or contamination.
Plain-English summary
Lusys Laboratories, Inc. is recalling 20 units of the Ebola Virus One Step Test Kits, Catalog No. I-123 (B), Lot No. 12292014B. The recall is being conducted to stop and prevent further use of these devices.
The FDA has determined that these test kits have not yet been cleared, approved, or authorized by the FDA for diagnostic 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 intended to prevent the use of unauthorized diagnostic devices.
The recalled product
- Product
- Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.
- 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. 12292014B
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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