Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 5 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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, but the source text does not report any illnesses, injuries, or deaths. Per the rubric, when no adverse events are reported and the hazard is theoretical (uncleared device), the score is capped at 3. However, given the specific nature of the defect (lack of clearance rather than active contamination or malfunction causing harm) and the small quantity (5 units), it aligns with a voluntary precautionary recall or minor regulatory issue, fitting the Moderate (2) or High (3) range. Given the explicit 'no reported illness' rule and the theoretical nature of the risk (using an uncleared device), a score of 2 is appropriate for a regulatory compliance recall without reported harm.
Plain-English summary
Lusys Laboratories, Inc. is recalling 5 units of the Ebola Virus One Step Test Kits (Catalog No. I-123 (A)). The recalled product includes a test device in a foil pouch, a lancet for blood testing with an alcohol pad, an extraction tube with a buffer vial for feces testing, and a swab for nasal testing.
The recall was initiated to stop and prevent further use of these devices. The source text states 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), Canada, Sierra Leone, and Denmark. Consumers and healthcare providers who possess these specific test kits should stop using them immediately.
The recalled product
- Product
- Ebola Virus Antigen Blood, Catalog No. I-123 (A) 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.
- Affected units
- 5
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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