The Food and Drug Administration (FDA) has issued a Class 1 recall for the Ebola Virus One-Step Test Kits (LuSys Laboratories). This test kit has not been cleared or approved by the FDA for in vitro diagnostic detection of Ebola Virus infection.
Results obtained from these test kits have demonstrated inaccuracy and should not be used as an in vitro diagnostic test for Ebola infection. False positive results may be life-threatening to the patients because they may be placed in an isolation cohort with Ebola infected patients. A false negative test result may also be life-threatening due to the lack or delay in treatment and the risk of infecting healthcare providers, family, and other close contacts.
LuSys has issued a letter to all affected customers advising them to stop use of the Ebola Virus One-Step Test Kits and to return the test kits back to the company. The affected devices were sold in California and exported to Sierra Leone, Canada, and Denmark between October 2014 and January 2015. All lots of Ebola Virus One-Step Test Kits are included in the recall.
For more information please visit FDA.gov.