Vaccines, Blood & Biologics
Recall of Rapid HIV Test Kits-Globus Media, Inc
DATE RECALL INITIATED:
February 4, 2005
PRODUCT:
Rapid HIV Test Kit
DISTRIBUTOR:
Globus Media, Inc
Montreal, Canada
REASON:
Rapid HIV Test Kits, marketed nationwide via the Internet, by Globus Media, were not reviewed for safety and effectiveness as required under U.S. law. Consequently, there is no assurance that the results from these kits are reliable.
DO NOT RELY ON ANY TEST RESULT FROM THESE RECALLED KITS.
Consumers who have these products should not use them.
Consumers who have used the RAPID HIV Test Kit, should consult a health care professional immediately to confirm any results.
FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - 2/7/2005
Contact FDA
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448