Herpes Test Kits Recalled due to Inaccurate Results

A class 1 recall has been issued by Focus Diagnostics for herpes simplex virus 1 and 2 and group A streptococcus infection test kits due to inaccurate test results. A class 1 recall is the most serious type of recall and is defined by the U.S. Food and Drug Administration (FDA) as “a situation in which there is a reasonable probability that the use or exposure to a violative product will cause serious health consequences or death.”

The tests involved in the recall were the Simplexa Herpes Simplex Virus 1 & 2 Direct and Simplexa Group A Strep Direct kits containing direct amplification discs. The discs were used together with molecular testing to detect the presence of herpes simplex virus (HSV) 1 and 2 or group A streptococcus (GAS). The devices had insufficient overlay between the sample reaction wells, which may cause leakage into adjacent wells, which may cause cross-contamination between samples, according to the FDA.

More than 1,650 devices that were manufactured from July 30, 2015 to February 11, 2016 were recalled in Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington, West Virginia, and Wisconsin, reported the FDA.

The devices include models numbers MOL2150, MOL1451, MOL1452, MOL2850, and MOL1455. Lot numbers affected are 2140887, 2140332, 2127423, 2159531, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 29230, 29232, 29233, 29453, 29670, 29691, 29671, 29845, 29847, 29848, 29690, 29669, 29692, 29846, 151682, 151685, 151686, 151871, 151918, 151996, 151997, 152055, 152107, 152108, 152359, 151917, 151915, 151995, 151998, 152057 and 152056.

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