Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing

[Posted 04/23/2015]

AUDIENCE: Infectious Disease, Emergency Medicine

ISSUE: The FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not been demonstrated to be accurate and should not be used as in vitro diagnostic tests for Ebola infection. A false positive result may be life-threatening by potentially placing the patient in an isolation cohort with Ebola infected patients. A false negative test result may be life-threatening by causing a lack or delay in treatment of the patient and risking infecting healthcare providers, family and other close contacts.

BACKGROUND: The tests are intended for use as an aid in the diagnosis of Ebola Virus infection. All lots of the Ebola Virus One-Step Test kits are affected by this recall. The affected devices were sold in California and exported internationally to Sierra Leone, Canada, and Denmark between October 2014 and January 2015.

RECOMMENDATION: On March 13, 2015, LuSys Laboratories, Inc. sent an Urgent Voluntary Medical Device Recall to all affected customers. The letter identified the product, problems, and the following actions for customers:

• Stop use of the Ebola Virus One-Step Test Kits
• Return the test kits to LuSys Laboratories, Inc.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/23/2015 - Recall Notice - FDA]