[Recalled] 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) — LuSys Laboratories is recalling Ebola Virus O
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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) |
|---|---|
| Brand / manufacturer | Lusys Laboratories, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1328-2015 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 13 March 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.