Reported Apr 15, 2015 · Terminated
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood…
Lusys Laboratories, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lusys Laboratories, Inc. · 10054 Mesa Ridge Ct Ste 118-120 · San Diego, CA · 92121-2946
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Test Device in foil pouch. |
| 2 | Lancet for Blood test and alcohol pad. |
| 3 | Extraction tube contain buffer vial (0.5ml) for feces test |
| 4 | Swab for Nasal test. |
- Lot codes and dates
- n/a
- Amount recalled
- 5 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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