A Medical Device Daily

The FDA yesterday reported on its web site that Harmony Brands (Oak Park, Michigan), a national distributor of health, cosmetic and other consumer products, has voluntarily recalled its B-Sure brand One-Step Home Pregnancy Test, because, the agency said, "its safety and efficacy can no longer be assured."

Harmony said that there have been no reports of failures of the product, and there have been no reports of injury or illness associated with their use.

The company said consumers who have unused and unexpired B-Sure brand One-Step Home Pregnancy Tests in their possession should not use the product and should return the test to the point of purchase for a refund. Additionally, women who have used the test may wish to contact their healthcare provider to verify the test results, Harmony Brands advised.

The tests that are the subject of the recall were sold throughout the U.S. in a variety of retail outlets, including Dollar Stores and convenience stores. The tests can be identified by the product label notation "B-sure" pregnancy test.

"Even though we have had no reports of any deficiencies in the product, to insure strict compliance with FDA regulations, we believe this recall is in the best interest of our customers," said a Harmony spokesperson. "We regret any inconvenience caused by the recall, and will take all necessary steps to insure the complete satisfaction of purchasers of Harmony Brand products."