Inspections, Compliance, Enforcement, and Criminal Investigations
May 25, 2012: Palm Beach Man Sentenced for Mislabeling Medical Test Kits
Wifredo A. Ferrer, United States Attorney for the Southern District of Florida, and David W. Bourne, Special Agent in Charge of the Food and Drug Administration Office of Criminal Investigation, Miami Field Office, announced today’s sentencing of defendant Jonathan Barash, 46, of Palm Beach, Florida. At today’s hearing, U.S. District Judge James I. Cohn, in Ft. Lauderdale, sentenced Barash to three years of probation, with 180 days home detention with electronic monitoring.
Barash owned and operated a company called AtFfirst diagnostics through which he sold to the general public various test kits for sexually transmitted diseases, including kits to test for HCV and hepatitis. The test kits, known as FirstVue HIV Test Kit and FirstVue HCV Test Kit, were manufactured in China, and required FDA approval prior to their sale in the United States. The kits sold by Barash lacked pre-market FDA approval and had no FDA-granted investigational device exemption. As such, the FDA considered the kits to be an adulterated medical devices.
According to documents filed in the case and statements made in court, Barash obtained the test kits from China, repackaged them and placed FirstVue labels and inserts in the boxes, then sent the kits by DHL to customers who ordered and paid for them online. Barash operated a website called “atfirstdiagnostics.com” and he used this website to advertise and sell the test kits. The website contained false statements about the company and the test kits, including statements that At First diagnostics developed and manufactured the test kits; that the test kits were FDA registered devices; and that At First diagnostics had offices in Ireland, Spain, California, New Jersey and New York.
U.S. Attorney Ferrer commended the investigative efforts of the agents of the FDA for their work in this matter. The case is being prosecuted by Assistant U.S. Attorney Jennifer Keene.
A copy of this press release may be found on the website of the United States Attorney's Office for the Southern District of Florida at http://www.usdoj.gov/usao/fls. Related court documents and information may be found on the website of the District Court for the Southern District of Florida at http://www.flsd.uscourts.gov or on http://pacer.flsd.uscourts.gov.