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Focus Diagnostics is recalling laboratory examination kits supplied with Simplexa Herpes Simplex Virus 1 & 2 Direct and Simplexa Group A Strep Direct kits containing the Direct Amplification Discs due to a defect that could yield false positive, false negative, or invalid test results. The issue involves poor lamination between the sample reaction wells, which may lead to leakage into adjacent wells causing cross-contamination between samples. Herpes Simplex virus 1 (HSV-1) is transmitted by oral-to-oral contact and causes symptoms such as cold sores and in some cases, genital herpes. Group A strep are bacteria that can cause a wide range of infections including strep throat or the skin infection impetigo. The recall involves Laboratory examination kits supplied with Simplexa™ Herpes Simplex Virus 1 & 2, and Simplexa™ Group A Strep Direct Amplification Discs and includes the model numbers MOL2150, MOL1451, MOL1452, MOL2850, and MOL1455 and the lot numbers 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, 152056.


Focus Diagnostics sent letters to its customers informing them of the recall and that replacement disks would be provided free of charge until the issue was resolved.
Sofia, the next generation in diagnostic testing takes rapid testing to a whole new level by integrating proven lateral-flow technology, proprietary advanced fluorescence chemistry and assay development techniques, all incorporated into a small bench top analyzer that can be used near patient and in laboratory settings.
Sofia rapid test kits are easy to use, which means Sofia can be adapted to the needs of any healthcare setting. Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source. The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and influenza B viral nucleoprotein antigens.
Inaccurate diagnostic test results may lead to improper patient treatment for Herpes or Strep, which may cause serious adverse health consequences, including death. The recall has been identified as a Class 1, the most serious type of recall and involves products in which use may cause serious injuries or death.


Herpes Simplex 2 (HSV-2) is a sexually transmitted infection that causes genital herpes, which causes painful blisters at the site of infection. From the small physician office laboratory to larger hospital labs or emergency departments, Sofia's high performance, objectivity, quality control, fail-safe measures, LIS capabilities and expanding test menu make Sofia the perfect solution for those looking to improve their rapid testing algorithm. A total of 1,658 devices affected by the recall were distributed to the following states: 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, Wisconsin.



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Comments
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  2. ELSAN 05.11.2013 at 19:24:42
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