LuSys Laboratories is recalling all lots of its Ebola Virus One-Step test kits because the kits haven’t been shown to be accurate for the disease.
A false positive result could be life-threatening by placing a patient in isolation with Ebola-infected patients, according to a March 13 recall notice posted to the FDA’s website last week. By contrast, a false negative test could cause a lack of or delay in treatment and risk infecting healthcare providers, family and close contacts.
The Class I recall affects devices sold in California and exported to Sierra Leone, Canada and Denmark between October 2014 and January 2015.
Individual items listed include: Ebola VP 40 IgX Serum/Plasma/Blood Cassette; Ebola GP IgX Blood, Serum/Plasma Cassette; Ebola VP IgG/IgM (Dual Strip) Blood/Serum/Plasma Cassette; Ebola VP IgX Blood, Serum/Plasma Cassette; Ebola VP IgG/IgM (Dual Strip) Blood/Serum/Plasma Cassette; Ebola Virus Antigen Blood; and Ebola Virus Antigen Nasal.
LuSys advised customers to stop using the tests and return them to the company.