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 and 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.



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:

(Date:11/12/2015)... 12, 2015  A golden retriever that stayed healthy ... (DMD) has provided a new lead for treating this ... Broad Institute of MIT and Harvard and the University ... Cell, pinpoints a protective gene ... disease,s effects. The Boston Children,s lab of Lou ...
(Date:11/10/2015)... YORK , Nov. 10, 2015 ... to behavioral biometrics that helps to identify and ... fraud. Signature is considered as the secure and ... the identification of a particular individual because each ... more accurate results especially when dynamic signature of ...
(Date:10/29/2015)... 29, 2015   MedNet Solutions , an innovative ... of clinical research, is pleased to announce that it ... (MHTA) as one of only three finalists for a ... Small and Growing" category. The Tekne Awards honor ... superior technology innovation and leadership. iMedNet™ ...
Breaking Biology News(10 mins):
(Date:11/25/2015)... 2 nouvelles études permettent d , ... les souches bactériennes retrouvées dans la plaque dentaire ... . Ces recherches  ouvrent une nouvelle voie ... de l,un des problèmes de santé les plus ... --> 2 nouvelles études permettent d , ...
(Date:11/25/2015)... ... 25, 2015 , ... A long-standing partnership between the Academy ... been formalized with the signing of a Memorandum of Understanding. , AMA Executive ... Karl Minter and Capt. Albert Glenn Tuesday, November 24, 2015, at AMA Headquarters ...
(Date:11/24/2015)... ... , ... The United States Golf Association (USGA) today announced Dr. Bruce Clarke, ... annually since 1961, the USGA Green Section Award recognizes an individual’s distinguished service to ... Clarke, of Iselin, N.J., is an extension specialist of turfgrass pathology in the department ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... event of the year and one of the premier annual events for pharmaceutical ... ran from 8–11 November 2015, where ISPE hosted the largest number of attendees ...
Breaking Biology Technology: