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.
Reported: April 15, 2015 Initiated: March 13, 2015 #Z-1329-2015
Product Description
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.
Details
- Recalling Firm
- Lusys Laboratories, Inc.
- Units Affected
- 1,015 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 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.. Recalled by Lusys Laboratories, Inc.. Units affected: 1,015 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-1329-2015.
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