Ebola Virus Antigen Nasal recall
Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 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.
Why was Ebola Virus Antigen Nasal 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 12292014B
- Product
- Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 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.
- Recalling firm
- Lusys Laboratories, Inc.
- Quantity
- 20 units
- Distribution
- Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
- Recall date
- April 15, 2015
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)