Lusys Laboratories, Inc. Recall: Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No.
Lusys Laboratories, Inc. Recall: Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Lusys Laboratories, Inc.; Product: Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (opti
| Recalling firm | Lusys Laboratories, Inc. |
|---|---|
| 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. |
| Reason for recall | 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark. |
| Recall initiated | 20150313 |
| Recall number | Z-1329-2015 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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