Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they 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. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Lusys Laboratories, Inc. is recalling 1,015 units of the Ebola Virus One Step Test Kits, Catalog No. I-101, Lot No. 12012014B. 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 classified this recall as Class I. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these devices.
Consumers and healthcare providers who possess these test kits should stop using them immediately. The recall is intended to prevent the use of unauthorized diagnostic devices.
The recalled product
- Product
- Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
- Manufacturer
- Lusys Laboratories, Inc.
- Hazard
- Affected units
- 1,015
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. 12012014B
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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