Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

FDA device recall Z-1332-2015 · posted 2015-04-09 · Terminated

Recall details

Recalling firm

Lusys Laboratories, Inc.

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.

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.

Root cause

No Marketing Application

Status

Terminated

Product code

N/A

Quantity affected

20 units

Distribution

Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

Date initiated

2015-03-13

Date posted

2015-04-09

Date terminated

2017-05-31

Location

San Diego, CA