Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 80 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
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 device for a high-risk pathogen (Ebola) that has not been authorized by the FDA. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported' (Score 3), as the use of an uncleared diagnostic tool poses a significant risk of misdiagnosis or delayed treatment, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Lusys Laboratories, Inc. is recalling 80 units of the Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette) test kits, Catalog No. I-102, Lot No. 11192014B. The recall is being conducted to stop and prevent further use of these devices. The affected products were distributed worldwide, including in the United States (specifically California), Canada, Sierra Leone, and Denmark.
The recall is necessary because the Ebola Virus One-Step Test Kits have not yet been cleared, approved, or authorized by the FDA for diagnostic purposes. The agency has not validated these devices for their intended use in diagnosing Ebola virus infection.
Consumers and healthcare providers who possess these test kits should stop using them immediately. The recall is limited to the specific lot number and catalog number identified in this notice.
The recalled product
- Product
- Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
- Manufacturer
- Lusys Laboratories, Inc.
- Affected units
- 80
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. 11192014B
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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