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FDA: Focus Diagnostics recalls HSV, GAS examination kits
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Focus Diagnostics has recalled its laboratory examination kits for herpes simplex virus 1 and 2 and group A streptococcus infection due to inaccurate test results, according to a press release. The FDA identified the event as a class 1 recall, as use of the devices may result in serious injuries or death.
Tests included 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 are used in combination with molecular testing to detect the presence of herpes simplex virus (HSV) 1 and 2 or group A streptococcus (GAS). According to the FDA, the devices had poor lamination between the sample reaction wells, which may cause leakage into adjacent wells, resulting in cross-contamination between samples. The FDA said this defect may yield false positive, false negative or invalid test results, leading to inadequate treatment.
Quest Diagnostics indicated that the issue with the direct amplification discs, manufactured by 3M, has been resolved in March. A company spokeswoman said Focus Diagnostics is confident in the quality of its manufacturing.
More than 1,650 devices manufactured from July 30, 2015 to Feb. 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, according to the FDA. The devices include model 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.
Editor’s note: The story was updated on April 15 to clarify the status of the recall. The editors regret the error.