Z-1333-2015 Class I Terminated
FDA device recall Z-1333-2015 was initiated by Lusys Laboratories, Inc. on March 13, 2015 and is designated Class I. 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 b… The recall status is terminated (terminated May 31, 2017). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2015
- Initiation Date
- March 13, 2015
- Termination Date
- May 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Code Information
Lot No. 12292014B