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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002