Focus Diagnostics Simplexa Test Kit Faces Recall

The U.S. Food and Drug Administration (FDA) has issued a rare recall of a laboratory test kit, claiming a fault in its manufacturing process could endanger patients.

The test in question is manufactured and distributed by Focus Diagnostics, based in Cypress, Calif. The test, branded as Simplexa, tests for the herpes simplex virus and the group A version of streptococcus bacteria. Focus’ specialty is on assay kits that rapidly test for herpes and similar viruses.

According to the FDA, the recall is connected 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. Inaccurate diagnostic test results may lead to improper patient treatment for herpes simplex or group A streptococcus and may cause serious adverse health consequences, including death.”

According to the regulatory agency, the recall affects 1,658 test kits that were manufactured between last July and this February.

The FDA regulates laboratory test kits as a medical device. It currently does not regulate tests that are designed to be performed in a laboratory setting.

Focus issued a statement trying to blunt the notion the FDA recall was an ongoing issue for the company, and point out that it had been resolved last March. The FDA did remark in its recall notice that Focus had taken corrective actions.

“There is no new product recall related to Simplexa Direct Test kits. In close collaboration with the FDA, we notified our customers in February 2016 about the affected test kits,” the company said. “We have since resolved the issue with the manufacturer of the discs, which were the principal source of concern. We are confident in the corrective actions that we have implemented.”

Takeaway: The Food and Drug Administration has issued a rare recall of a laboratory test kit.