Medical Device Safety and Recalls: Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results

Focus Diagnostics is recalling Simplexa™ Herpes Simplex Virus 1 & 2 Direct and Simplexa™ Group A Strep Direct kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells. This poor lamination may lead to leakage into adjacent wells causing cross-contamination between samples, which could yield false positive, false negative, or invalid test results. Inaccurate diagnostic test results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.

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