[U.S. Food and Drug Administration]

Warning Letters Issued for Unapproved HIV Test Kits


Warning Letters (WL) are an informal advisory to a firm communicating the agency's position on a matter but does not commit FDA to taking enforcement action. The agency's policy is that Warning Letters should be issued for violations which are of regulatory significance in that failure to adequately and promptly take corrections may be expected to result in enforcement action should the violation(s) continue.  None of the products below are approved for sale by the Food and Drug Administration.

Akers Laboratories
Thorofare, New Jersey 08086
HealthTest HIV 1 + 2 Rapid Assay Test Kits
Hepatitis B Surface Antigen (HBsAg) Test Kits
WL issued on 10/30/98
http://www.fda.gov/foi/warning_letters/m2195n.pdf

 

Alfa Scientific Designs, Inc.
San Diego, CA 92121
Lateral Flow Rapid HIV 1/2 Whole Blood Test
(Regular Cassette) Test Kit
WL issued on November 2, 1999
http://www.fda.gov/foi/warning_letters/m3139n.pdf

 

Americare Biologicals
Miami, FL 33169
Ana-Sal HIV Test Kits
WL issued on 3/3/97
http://www.fda.gov/foi/warning_letters/d1233b.pdf

Biokwitech, Inc.
San Diego, CA 92121
HIV 1/2, HBsAg, and HBsAb
WL issued on 7/23/97 &8/29/97
http://www.fda.gov/foi/warning_letters/m650n.pdf
and 8/29/97
http://www.fda.gov/foi/warning_letters/m564n.pdf

Cal-Test Diagnostics, Inc.
Chino, CA 91710
Red Dot HIV 1&2
WL issued on 3/26/97
http://www.fda.gov/foi/warning_letters/d1291b.pdf

Chembio Diagnostics Systems, Inc.
Medford, NY 11793
HIV 1/2 STAT-PAK ULTRA FAST
WL issued on 7/6/99
http://www.fda.gov/foi/warning_letters/m2761n.pdf

MD-HLP, Inc.
Indian Rocks Beach, FL 33785
Red Dot HIV 1+2 Diagnostic Test Kit
WL issued on 4/7/97
http://www.fda.gov/foi/warning_letters/m806n.pdf

MD-LNK HCC, Inc.
Plant City, FL 33567
Red Dot HIV 1+2 Diagnostic Test Kit
WL issued on 4/7/97
http://www.fda.gov/foi/warning_letters/m807n.pdf

Pan Probe Biotech, Inc.
San Diego, CA 92126
WL issued on 5/27/99
http://www.fda.gov/foi/warning_letters/m2667n.pdf

Phamatech, Inc.
San Diego, CA 92126
HIV Test
WL issued on 10/7/97
http://www.fda.gov/foi/warning_letters/m330n.pdf

Simplex Medical Systems, Inc.
Hallandale, FL 33009
Saliva HIV Rapid Test Kits
WL issued on 6/16/97
http://www.fda.gov/foi/warning_letters/m1002n.pdf

Sovo Tec Diagnostics
Novato, CA 944947
HIV 1/2 STAT-PAK ULTRA FAST and HIV 1/2 Whole Blood test kit
WL issued on 10/1/99
http://www.fda.gov/foi/warning_letters/m3018n.pdf

United Biotech, Inc.
Mountain View, CA 94041-1517
UBI-Magiwel, HIV I/II Spot Test
WL issued on 8/29/97
http://www.fda.gov/foi/warning_letters/m580n.pdf

 

Complied by:
Division of Case Management, HFM-610
Office of Compliance
Center for Biologics Evaluation and Research

Revised January 19, 2000
Office of Special Health Issues, HF-12
Office of International and Constituent Relations

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