04.24.15
The U.S. Food and Drug Administration (FDA) has recalled LuSys Laboratories Inc.’s Ebola Virus One-Step Test Kits, which were neither cleared nor approved by the agency. According to the FDA, 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. Similarly, 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 recall was initially issued in mid-March for test kits exported to Denmark, Sierra Leone and Canada between October 2014 and January 2015. The April recall concerns all lots of the kits.
The FDA did not say how many tests were sent out.
The recall is described as a Class I, the most serious type of recall. Class I involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
San Diego, Calif.-based LuSys Laboratories did not make any comment.
The recall was initially issued in mid-March for test kits exported to Denmark, Sierra Leone and Canada between October 2014 and January 2015. The April recall concerns all lots of the kits.
The FDA did not say how many tests were sent out.
The recall is described as a Class I, the most serious type of recall. Class I involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
San Diego, Calif.-based LuSys Laboratories did not make any comment.