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i came across this on the net.. thought it might be useful....
April 2005

Unreliable home pregnancy tests recalled

The accuracy of hundreds of thousands of home pregnancy test kits sold under the "B-Sure" brand name has been called into question because the kits could give false-positive or false-negative results.

Harmony Brands of Oak Park, Mich., which distributed the B-Sure One-Step Home Pregnancy Test kits, has voluntarily recalled them. The kits were sold at various outlets, including convenience and dollar-type stores, but not at pharmacies. In a nationwide alert issued on March 25, 2005, the Food and Drug Administration recommended that women who had recently used a B-Sure test kit visit a health-care professional for retesting to confirm the results. The kits had been on sale since February 2003. By the time they were pulled from store shelves, the FDA says, 627,216 test kits had been made, distributed, or used.

A routine FDA inspection of imported goods uncovered the potential problems with the pregnancy test kits, FDA spokeswoman Cathy McDermott told us. In a statement from the company included in an FDA press release, Harmony Brands maintained that there have been no reports of actual product failures, injuries, or illnesses associated with the tests. The company did not respond to our requests for additional information.

Pregnancy tests that give the wrong results could have serious safety consequences, according to McDermott. A woman who does not know she is pregnant may use medications, drink alcohol, or engage in behavior that could harm the fetus. Conversely, if a woman incorrectly assumes she is pregnant, she may avoid taking drugs for other conditions or seek unnecessary medical care, McDermott said in a written response to questions from Consumer Reports.
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