Ebola Virus Test Kits Recalled
United States regulators have issued a recall of a 10-minute Ebola blood test due to the possibility that the product does not work and could cause potential health risks.
About the Ebola Virus One-Step Test Kit Recall
A Class I recall has been issues on the LuSysLaboratories, Inc. Ebola Virus One-Step Test Kits due to the fact that it does not have Food and Drug Administration (FDA) clearance.
According to the FDA, the product has not been approved for use or sale as the product could produce a false positive. A false positive could result in life-threatening circumstances if a virus free consumer is place in isolation with Ebola-infected patients.
LuSys Laboratories, based in California, claims that early trials of the kits show an 86 percent accuracy rate. However, the FDA found issue with the equipment not being labeled “for research purposes only.”
The FDA states that the kits have not demonstrated sufficient data to be used as an in vitro diagnostic test for Ebola infection. The recall was issued mid-March and applies to all test kits that were exported to Denmark, Sierra Leone, and Canada between October 2014 and January 2015.
About Class 1 Recalls
The FDA develops a strategy for each recall they administer after carefully and extensively investigating a company and the product in question. Class I recalls are the most serious type of recalls issued by the FDA.
They are issued for products that prove to be dangerous or defective, and can cause serious or fatal health risks. Examples of products that have been recalled and fell into the Class I category are foods found to contain botulinal toxins, foods with undeclared allergens, label mix-ups on a life saving drug, or defective artificial heart valves.