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FDAnews Device Daily Bulletin

Focus Diagnostics Recalls Lab Kits Due to Invalid Results

April 18, 2016

Focus Diagnostics is recalling Simplexa herpes simplex virus 1 and 2 direct and Simplexa group A strep direct kits containing direct amplification discs because of poor lamination between sample reaction wells.

The company initiated the recall — which has been labeled Class 1 — because poor lamination may lead to leakage causing cross-contamination between samples.

The FDA notice warns that inaccurate diagnostic results could potentially lead to improper treatments of HSV or GAS or cause adverse events, including death.

The recall involves units manufactured between July 30, 2015 and Feb. 11, and distributed between Sept. 16, 2015 and Feb. 11. — Anisa Jibrell