All lots of the Ebola Virus One-Step Test kits have been recalled. The tests were distributed by LuSys Laboratories, Inc., San Diego, CA. The affected devices were sold in California and exported internationally to Sierra Leone, Canada, and Denmark between October 2014 and January 2015. The tests are intended for use as an aid in the diagnosis of Ebola Virus infection.
These devices do not have FDA clearance or Emergency Use Authorization (EUA) for in vitro diagnostic detection of Ebola virus. 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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The World Health Organization (WHO) has issued warnings about other unapproved Ebola tests. Some have been packaged with labels bearing the FDA and WHO logos, which may be wrongly interpreted as the product having undergone assessment by the FDA and WHO regarding its quality, safety and performance.
See the Recall
See the World Health Organization Announcement
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks