Class I Medical Device Recall: 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
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news