Navigation Links
FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media

The Food and Drug Administration (FDA) is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada. The use of these products could result in false results that could lead to significant adverse health consequences. The illegal kits are labeled as: Rapid HIV Test Kit.

* Rapid Syphilis Test Kit
* One Step Cassette Style Cocaine Test
* One Step Cassette Style Marijuana (THC) Test
* One Step Cassette Style Amphetamine Test
* Rapid Dengue Fever Test
* One Step Midstream Style HCG Urine (Home)
* Pregnancy Test

FDA learned of the problem from two consumer complaints.

FDA has not approved or evaluated the performance of any of Globus Media's products. As a result, consumers cannot know with any degree of certainty that test results are correct. For example, a person testing positive for HIV (human immunodeficiency virus, or the AIDS virus) using one of these tests may not be infected with HIV, or, worse, someone infected with HIV may test negative and not seek medical treatment or spread the virus to others.

The tests were sold through websites and distributed throughout the U.S., usually by overnight delivery services. These have been made available for sale on several websites, including www.htkit.com and www.hstkits.com. The kits usually are contained in a paper envelope with instructions inside the packaging. The envelope, instructions and packaging may not accurately identify the manufacturer, packer or distributor. The name of the kit appears on the instructions.

Consumers who have these products should not use them. Anyone who has used one of these test kits should be retested using valid test methods. Only one HIV home collection test system is approved by FDA and legally sold in the United States. This test, sold as either "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System" is manufactured by Home Access Health Corporation and allows blood samples to be taken at home which people then send to a laboratory for testing. No home-use test kits intended for diagnosing syphilis and dengue fever are approved for sale in the U.S.

The FDA has issued an import alert which alerts FDA field personnel to the possible importation of the Globus Media devices, provides guidance as to their detention and refusal of admission into the U.S., and also advises U.S. Customs officials about these products.


'"/>

Source:FDA


Related biology news :

1. WHO Warns Of Increased Risk Of Vector-borne Diseases In Tsunami-affected Areas
2. FDA Warns About Antipsychotic Drugs and Elderly
3. Nanoscale Diagnostic Sets Sights on Alzheimers
4. Affymetrix and bioMerieux Extend Their Agreement on GeneChip(R) Technology to Breast Cancer Diagnostics
5. FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:4/5/2017)... 2017 KEY FINDINGS The global ... a CAGR of 25.76% during the forecast period of ... factor for the growth of the stem cell market. ... MARKET INSIGHTS The global stem cell market is ... geography. The stem cell market of the product is ...
(Date:3/30/2017)... YORK , March 30, 2017 Trends, ... type (physiological and behavioral), by technology (fingerprint, AFIS, iris ... voice recognition, and others), by end use industry (government ... and immigration, financial and banking, and others), and by ... Europe , Asia Pacific , ...
(Date:3/24/2017)... , Mar 24, 2017 Research and Markets ... System Market Analysis & Trends - Industry Forecast to 2025" ... ... grow at a CAGR of around 15.1% over the next decade ... industry report analyzes the market estimates and forecasts for all the ...
Breaking Biology News(10 mins):
(Date:9/22/2017)... ... September 22, 2017 , ... ... will host a booth at premier packaging event PACK EXPO International in Las ... Packaging Machinery Manufacturers Institute (PMMI). , At this year’s PACK EXPO at the ...
(Date:9/21/2017)... ... ... Greg Leyer, Chief Scientific Officer of UAS Labs, will be presenting at SupplySide West ... Probiotics Resource Center, Mandalay Bay Expo Hall. , “I am very pleased to ... data in areas outside the gut including heart health, Vitamin D status, upper respiratory ...
(Date:9/21/2017)... ... September 21, 2017 , ... When a downtown Greenville ... was swift and efficient thanks to the continuing efforts of members of the ... more than 50 stakeholders, including officials from area counties and cities, Renewable Water ...
(Date:9/20/2017)... ... September 20, 2017 , ... Diversity focused business accelerator, ... Fueling the Growth pitch competition to uncover the top technology-driven, women-led startups in Boston, ... integral part of each city’s entrepreneurial events going on that week – in Boston, ...
Breaking Biology Technology: