Lusys Laboratories Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes."
Plain-English summary
Lusys Laboratories, Inc. is recalling 1,055 units of the Ebola IgX VP-40 Serum/Plasma/Blood Cassette, also known as the Ebola Virus One Step Test Kit (Catalog No. I-100). The recall is being conducted to stop and prevent further use of these devices. The affected products are identified by Lot No. 12012014B.
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 devices were distributed worldwide, including in the United States (specifically California), Canada, Sierra Leone, and Denmark.
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 IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
- Manufacturer
- Lusys Laboratories, Inc.
- Hazard
- Affected units
- 1,055
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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