On February 10, 2016, Focus Diagnostics recalled 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.
The Direct or Group A Streptococcus (GAS).Amplification Discs are Simplexa kit components used in combination with a molecular testing system (thermal cycler or thermocycler) to detect the presence of herpes simplex virus (HSV). Inaccurate diagnostic test results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.
The Model Numbers recalled are MOL2150, MOL1451, MOL1452, MOL2850, and MOL1455. These were manufactured from July 30, 2015 to February 11, 2016.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks