Class 1 Herpes Test Kits Face Dilemma. Herpes is a highly contagious chronic condition caused by a virus. Many individuals never experience symptoms even though they carry the virus.
The HSV1 is oral herpes and symptoms generally include cold sores or blisters. It can be spread through kissing or sharing toothbrushes or eating utensils, for example.
HSV2 herpes is normally below the waist and usually spread through sexual contact, according to WebMD.
A class 1 recall has been issued by Focus Diagnostics for tests kits for herpes simplex virus 1 and 2 and group A streptococcus infection 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 in connection with molecular testing to detect the presence of herpes simplex virus (HSV) 1 and 2 or group A streptococcus (GAS).
The devices had poor lamination between the sample reaction wells, which may cause leakage into adjacent wells, causing cross-contamination between samples, according to the FDA.
Devices Model Numbers
Over 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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