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:6/9/2016)... 2016  Perkotek an innovation leader in attendance control systems is proud to announce ... for employers to make sure the right employees are actually signing in, and to ... ... ... ...
(Date:6/2/2016)... --  The Weather Company , an IBM Business (NYSE: ... in which consumers will be able to interact with IBM ... voice or text and receive relevant information about the product ... have long sought an advertising solution that can create a ... and valuable; and can scale across millions of interactions and ...
(Date:5/16/2016)... , May 16, 2016   EyeLock LLC , ... announced the opening of an IoT Center of Excellence ... and expand the development of embedded iris biometric applications. ... level of convenience and security with unmatched biometric accuracy, ... identity aside from DNA. EyeLock,s platform uses video technology ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... June 27, 2016 , ... Rolf K. ... the faculty of the University of North Carolina Kenan-Flagler Business School ... entrepreneurship at UNC Kenan-Flagler, with a focus on the school’s international efforts, leading ...
(Date:6/27/2016)... , June 27, 2016   Ginkgo Bioworks , ... industrial engineering, was today awarded as one of ... of the world,s most innovative companies. Ginkgo Bioworks ... for the real world in the nutrition, health ... work directly with customers including Fortune 500 companies ...
(Date:6/24/2016)... , June 24, 2016 Epic Sciences ... detects cancers susceptible to PARP inhibitors by targeting ... cells (CTCs). The new test has already been ... in multiple cancer types. Over 230 ... damage response pathways, including PARP, ATM, ATR, DNA-PK ...
(Date:6/24/2016)... ... , ... Researchers at the Universita Politecnica delle Marche in Ancona combed medical ... mesothelioma. Their findings are the subject of a new article on the Surviving Mesothelioma ... in the blood, lung fluid or tissue of mesothelioma patients that can help point ...
Breaking Biology Technology: