Device recall
Z-1329-2015: Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials…
FDA device recall · Class I · Lusys Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1329-2015 |
|---|---|
| Recall event | 70668 |
| 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. |
| Recalling firm | Lusys Laboratories, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 31, 2017 |
| FEI number | 3004473533 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database