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)
Reported: April 15, 2015 Initiated: March 13, 2015 #Z-1328-2015
Product Description
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)
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.
Details
- Recalling Firm
- Lusys Laboratories, Inc.
- Units Affected
- 1,055 units
- Distribution
- Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
- Location
- San Diego, CA
Frequently Asked Questions
What product was 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). Recalled by Lusys Laboratories, Inc.. Units affected: 1,055 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2015. Severity: Critical. Recall number: Z-1328-2015.
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