Medical Device Safety and Recalls: LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits - Not Cleared for Marketing

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits - Not Cleared for Marketing

A recall has been issued for the LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits because the FDA has not cleared or approved the kits for use or sale. The results obtained from these test kits have not 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.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm444162.htm

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