Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
- Company
- Lusys Laboratories, Inc.
- Recall Initiated
- March 13, 2015
- Posted
- April 9, 2015
- Terminated
- May 31, 2017
- Recall Number
- Z-1332-2015
- Quantity
- 20 units
- Firm Location
- San Diego, CA
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
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Lot / Code Info
Lot No. DEI007963
Root Cause
No Marketing Application
Action Taken
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688. For questions regarding this recall call 858-546-0902.