NEW YORK (GenomeWeb) – The US Food and Drug Administration posted a notice today of a Class I recall for Focus Diagnostics' Simplexa kits for herpes simplex virus 1 and 2 and Group A Streptococcus, which contain Direct Amplification Discs.
The recalled devices are used in combination with molecular testing systems to detect the presence of herpes and strep. Focus Diagnostics (a subsidiary of Quest Diagnostics) instituted the recall on February 10 "due to poor lamination between the sample reaction wells," the agency said in its notice. "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."
Quest spokesperson Wendy Bost told GenomeWeb that the firm is confident it resolved this issue in March. "We worked closely with the FDA and our customers to resolve the issue," she said, "as well as the manufacturer of the component that was the principle source of concern." 3M manufactures the Direct Amplification Discs, according to Bost.
Focus distributed the recalled products between Sep.16, 2015 and Feb. 11, 2016. Focus has recalled 1,658 of these devices across more than 20 states.
Class I recalls are "the most serious type of recall," the FDA said, since the "use of these devices may cause serious injuries or death." Specifically, inaccurate test results due to faulty Direct Amplification Discs could result in improper treatment of patients with herpes or strep, and "may cause serious adverse health consequences, including death," the agency added.
The FDA further noted that Focus sent a correction letter informing customers that the firm would provide extra discs for free until the issue was resolved. The company told customers to check their inventories for defective products, only run full discs, not run partially used discs, and discard discs after a partial run.
Additionally, customers should let Focus know that they received its letter and report adverse events or quality problems with these discs to FDA's MedWatch.