DATE RECALL INITIATED:
PRODUCT:
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
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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