Ebola GP IgX Blood — Class I medical device recall Z-1329-2015
Terminated recall by Lusys Laboratories, Inc., reported 2015-04-15, distributed in CA. LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these device
| Recall number | Z-1329-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lusys Laboratories, Inc., San Diego, CA, United States |
| Recall initiated | 2015-03-13 |
| Classified | 2015-04-09 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2017-05-31 |
| Distributed | CA |
| Countries outside the US | CA, DK |
| Quantity | 1,015 units |
| Lot numbers | 12012014B |
| Model numbers | I-101 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1329-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.