Focus Recalls Lab Exam Kits

FDA says that Focus Diagnostics has recalled specific lots of its laboratory examination kits supplied with Simplexa herpes simplex virus 1 & 2 and Simplexa Group A strep direct amplification discs. The agency notice says that the kits were manufactured between 7/30/15 and 2/11/16, and were distributed between 9/16/15 and 2/11/16.

The kits are being recalled due to poor lamination between the sample reaction wells that may lead to leakage into adjacent wells causing cross-contamination between samples. Cross-contamination could result in false positive, false negative, or invalid test results, FDA says. The agency notice says that inaccurate diagnostic test results could lead to improper treatment for herpes simplex virus or Group A streptococcus and could cause serious adverse health consequences, including death.

FDA has designated this a Class 1 recall.